Instructions Case Report Forms by hzp22842

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									                                                                                                          instructions CRITICS

L U         Dept. of
MC          Surgery

Dutch Colorectal Cancer Group
Leiden University Medical Center
Department of Surgery
Datacenter, K6-R
P.O. Box 9600
2300 RC LEIDEN
E-mail   datacenter@lumc.nl
Phone    +31 (0) 71 526 3500
Fax      +31 (0) 71 526 6744


                                                 CRITICS TRIAL
          ChemoRadiotherapy after Induction chemoTherapy In Cancer of
                                 the Stomach
      A multicenter randomised phase III trial of neo-adjuvant chemotherapy followed
           by surgery and chemotherapy or by surgery and chemoradiotherapy
                              in resectable gastric cancer

                                                          CKTO 2006-02




                                      Instructions
                                   Case Report Forms
                                                   Including changes due to

                                   Amendment 1, protocol version 8.0; change of endpoints
                                   Amendment 2, protocol version 9.0; weekly cisplatin
                                   Amendment 3, protocol version 10.0; oxaliplatin for Sweden
                                   Amendment 4, protocol version 11.0; data monitoring (and description
                                   of surgery)




                                                          May 2009
                                                                                      instructions CRITICS

ADMINISTRATIVE RESPONSIBILITIES

Principal Investigators

E.P.M. Jansen MD, radiation oncologist             A. Cats MD PhD, gastroenterologist/medical oncologist
The Netherlands Cancer Institute/                  The Netherlands Cancer Institute/
Antoni van Leeuwenhoek hospital                    Antoni van Leeuwenhoek Hospital
Department of Radiation Oncology                   Department of Gastroenterology and Hepatology
Plesmanlaan 121, 1066 CX Amsterdam                 Plesmanlaan 121
The Netherlands                                    1066 CX Amsterdam
T 31 20 5122124                                    The Netherlands
F 31 20 6691101                                    T 31 20 512 2566
E epm.jansen@nki.nl                                F 31 20 512 2572
                                                   E a.cats@nki.nl
Prof. M. Verheij MD PhD, radiation oncologist
The Netherlands Cancer Institute/                  Prof. G.A. Meijer MD PhD, pathologist
Antoni van Leeuwenhoek hospital                    Free University Medical Center
Department of Radiation Oncology                   Department of Pathology
Plesmanlaan 121, 1066 CX Amsterdam                 PO Box 7057
The Netherlands                                    1007 MB Amsterdam
T 31 20 5122124                                    T 31 20 4444852
F 31 20 6691101                                    F 31 20 4442964
E m.verheij@nki.nl                                 E ga.meijer@vumc.nl

Prof. C.J.H. van de Velde MD PhD, surgeon          Prof. N.K. Aaronson, Ph.D, psychologist
Leiden University Medical Center                   The Netherlands Cancer Institute/
Department of Surgery                              Antoni van Leeuwenhoek Hospital
PO Box 9600, 2300 RC Leiden                        Division of Psychosocial Research & Epidemiology
The Netherlands                                    Plesmanlaan 121
T 31 71 5262309                                    1066 CX Amsterdam
F 31 71 5266750                                    The Netherlands
E C.J.H.van_de_Velde@lumc.nl                       T 31 20 512 2481
                                                   F 31 20 512 2322
H. Boot MD PhD, gastroenterologist                 E n.aaronson@nki.nl
The Netherlands Cancer Institute/
Antoni van Leeuwenhoek Hospital                    H. Putter PhD, statistician
Department of Gastroenterology and Hepatology      Leiden University Medical Centre
Plesmanlaan 121                                    Department of Medical Statistics
1066 CX Amsterdam                                  PO Box 9600
The Netherlands                                    2300 RC Leiden
T 31 20 512 2566                                   The Netherlands
F 31 20 512 2572                                   T 31 71 5269705
E h.boot@nki.nl                                    F 31 715276799
                                                   E h.putter@lumc.nl


Central Datacenter                                 Study coordinator
Ms. W.M. Meershoek – Klein Kranenbarg, MSc         H.A.M. Swellengrebel MD
R.E. Zwaan                                         m.swellengrebel@nki.nl
Leiden University Medical Center                   Department of Gastroenterology and Hepatology
Datacenter Surgery K6-R                            The Netherlands Cancer Institute/ AvL
P.O. Box 9600, 2300 RC Leiden                      Plesmanlaan 121
T 31 71 526 3500                                   1066 CX Amsterdam
F 31 71 526 6744                                   The Netherlands
E datacenter@lumc.nl                               phone: +31 20 512 2323
                                                   mobile (after-hours): +31 6 425 83362

Independent Physician
Dr. J.M. Kerst, the Netherlands Cancer Institute
T 31 20 5122951
                                                                                                  instructions CRITICS

GENERAL GUIDELINES

All data completed on the CRFs must comply with the source data of the patient.
All CRFs should be dated and signed by the investigator or her/his authorised staff members.

   The CRF must always be completed in English.
   The CRF is available at www.DCCG.nl. Send the original CRF to the central datacenter and keep a copy. To
    ensure that all entries are clear on each sheet, please write firmly.
   The CRF package contains all CRFs for one patient for the whole study.
   Write neatly and legibly. Record responses in check boxes using "x" or "" or ■.
   Use a ballpoint pen with black or blue ink.
   Use abbreviations sparingly and only use abbreviations that are clear and in standard medical use.
   Record the Center Id (= hospital number allocated by the Datacenter), Subject Id (= starts standard with a 4,
    followed by patient serial number within the hospital, e.g. 4001= first patient in specific hospital), Date of
    Birth, Chart Number (= patient hospital chart number) and/or Patient Initials (= first letter of first name and
    first two letters of maiden name) at the top of each CRF page.
   Make reference to the patient using only the above mentioned patient identifiers.
   Record all laboratory values only in the units given at the CRF.
   Do not leave blank spaces. Use the following abbreviation for information that is missing.
            o   ND = not done.
            o   NA = not applicable.
            o   UNK = unknown.
   Where a date is required, enter the date of the assessment, not the date the results of the assessment were
    reported or the date the CRF was completed.
   Record dates in the format dd/mm/yyyy.
   Ensure that the ‘other’ category is only used for data which does not fit in one of the listed categories and
    specify.
   Make comments as clear and concise as possible. Do not enter data or comments on the page margins or
    outside the allocated spaces but use the ‘Comment Form’ in the CRF booklet.
   To correct an error.
            o   Draw a single line through the incorrect entry; do not write over, erase or use correction fluid.
            o   Enter the correct data nearby.
            o   Date and initial the correction.
   The CRFs must be completed and signed by the investigator or one of his/her authorised staff members as
    soon as the requested information is available. The time between the patient’s visit and completion/shipment
    of CRF pages should be kept to a reasonable minimum. In all cases it remains the responsibility of the
    investigator to check that original CRFs are sent to the Datacenter in Leiden and to verify that they are
    completed and filled out correctly.
   To enable peer review and/or audits from Health Authorities/DCCG, the investigator must agree to keep
    records, including a file to identify all participating subjects (Patient Name and Subject Id), all original signed
    Informed Consent Forms, all copied CRFs. To comply with international regulations, the records should be
    retained by the investigator for 15 years, including assessments like CT/MRI scans.




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                                                                                       instructions CRITICS

CRF                                Form Comment
Randomisation Form                 F01    Complete within 1-2 months after randomisation.
Baseline Form                      F02    Complete within 1-2 months after randomisation.
Preoperative chemotherapy form     F03    Complete within 1-2 months after completion chemotherapy.
Surgery Form                       F04    Complete within 1-2 months after surgery.
Pathology Form                     F05    Complete within 1-2 months after surgery.
Postoperative chemotherapy Form    F06a   Complete within 1-2 months after completion chemotherapy.
                                          Only applicable for patients randomised for 3x ECC (for
                                          Sweden 3x EOC) postoperatively.
Postoperative chemoradiation       F06b   Complete within 1-2 months after completion chemotherapy.
Form                                      Only applicable for patients randomised for postoperative
                                          chemoradiation.
Postoperative Radiotherapy Form    F07    Complete within 1-2 months after completion radiotherapy.
                                          Only applicable for patients randomised for postoperative
                                          chemoradiation.
Adverse Event Form(s)              F08    To record every new adverse event. Give a sequential
                                          number to the events. Complete this form within 1-2 months
                                          after the adverse event. Surgical procedures, new primaries,
                                          relapses are not AEs.
End of Study Treatment Form        F09    Complete within 1-2 months after the patient has completed
                                          the allocated treatment or in case of early discontinuation.
Follow-up Form(s)                  F10    To fill in after every visit, complete within 2 months after each
                                          visit. Follow-up starts after End of Study Treatment.
                                          Month 1
                                          Month 2
                                          Month 3
                                          Month 6
                                          Month 12
                                          Month 18
                                          Month 24
                                          Month 30
                                          Month 36
                                          Month 42
                                          Month 48
                                          Month 54
                                          Month 60
                                          Additional visit To be used for visits in between protocol
                                                           visits or for visits after 5 years.
Recurrence / New Primary Form(s)   F11    To fill in for every separate occurrence of an event
                                          (locoregional recurrence, distant metastases or new
                                          primary). Complete this form within 1-2 months after all
                                          treatments have started.
Off Study Form                     F12    To fill in when patient/investigator decides to stop the whole
                                          study. Complete this form within 2 months.
Death Form                         F20    To record date and cause of death. Complete this form within
                                          2 months after death.
Serious Adverse Event Form(s)      F40    To record every new serious adverse events. Report a
                                          serious adverse event by fax to the NKI/AvL Trial Office in
                                          Amsterdam within 24 hours and by regular mail within 10
                                          days of the initial observation of the event.
Comment Form(s)                    F50    To record any comment and additional data.




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                                                                                                                     instructions CRITICS

F01      RANDOMISATION FORM

The first number refers to the general item, e.g. 2 = inclusion criteria. The second number (bold on the CRF) refers to the
number of each question at the beginning of the line. The third and fourth number refers to sub questions. E.g. question 4.5.1
is: 4. Specific questions – 5. Randomisation – 1. Allocated Treatment


1. GENERAL INFORMATION
 1.1      Physician is the person who is responsible for the randomisation of the patient.
 1.2      Center is the center where the chemotherapy and surgery will take place.


2. INCLUSION CRITERIA
 2.2      World Health Organisation (WHO) Performance Status. Patients with WHO > 2 are ineligible.
          0         Fully active; able to carry on all pre-disease performance (normal activity) without restriction.
          1         Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature.
          2         Ambulatory & capable of all self-care but unable to carry out any work activities; up and about > 50% of waking hours.
          3         Capable of only limited self-care; confined to bed or chair more than 50% of waking hours.
          4         Completely disabled; cannot carry on any self-care; totally confined to bed or chair.
          5         Dead.
 2.4      Amendment 4: Operable adenocarcinoma of the stomach or gastro-esophageal junction.
 2.6      Hb=Hemoglobin ≥ 5.0 mmol/L equals ≥ 80.50 g/L
 2.9      Left ventricular ejection fraction. Amendment 3: in Sweden only applicable for patients with a history of cardiac
          disease or with cardiac symptoms
 2.14     Amendment 4: Caloric intake  1500 kcal/day, verified by a dietician before registration


3. EXCLUSION CRITERIA
 3.12     Hearing: patients without baseline audiogram and not enrolled in a monitoring program . Patients with
          grade > 2 are ineligible
          2         Hearing loss not requiring hearing aid or intervention (i.e., not interfering with ADL)
          3         Hearing loss requiring hearing aid or intervention (i.e., interfering with ADL)
          4         Profound bilateral hearing loss (>90 dB)
 3.12     Hearing: patients with/without baseline audiogram and enrolled in a monitoring program. Patients with
          grade > 2 are ineligible
          1         Threshold shift or loss of 15 - 25 dB relative to baseline, averaged at 2 or more contiguous test frequencies in at least
                    one ear; or subjective change in the absence of a Grade 1 threshold shift
          2         Threshold shift or loss of >25 - 90 dB, averaged at 2 contiguous test frequencies in at least one ear
          3         Adult only: Threshold shift of >25 - 90 dB, averaged at 3 contiguous test frequencies in at least one ear Pediatric:
                    Hearing loss sufficient to indicate therapeutic intervention, including hearing aids (e.g., >=20 dB bilateral HL in the
                    speech frequencies; >=30 dB unilateral HL; and requiring additional speech-language related services)
          4         Adult only: Profound bilateral hearing loss (>90 dB) Pediatric: Audiologic indication for cochlear implant and requiring
                    additional speech-language related services
 3.13     Neurotoxicity > CTC grade 1 equals
          To be added.


4. SPECIFIC QUESTIONS
 4.3.2    Tumour location in cardia equals proximal location.
 5.1      For Sweden ECC is replaced by EOC (epirubicin, oxaliplatin, capecitabine)




                                                                                                                                     5 of 15
                                                                                                           instructions CRITICS

F02      BASELINE FORM

1. CLINICAL CHARACTERISTICS
 1.2.2   In case of previous malignancy, patient must be disease free for at least 5 years, otherwise patient is ineligible.



3. DISSIMINATION INVESTIGATIONS
 3.4     PET scan is optional.
 3.5     Diagnostic laparoscopy in case of suspicion of peritoneal carcinomatosis.

4. LABORATORY TESTS
 4.1     Fill in this date if all tests have been performed at the same day. Skip the rest of the dates
 4.1.1   Hemoglobin should be reported in mmol/L. The following table can be used to change g/L into mmol/L.
         To convert g/L to mmol/L divide by 16,1



  Hemoglobin           Hemoglobin             Hemoglobin            Hemoglobin             Hemoglobin           Hemoglobin
       g/L               mmol/L                    g/L                mmol/L                    g/L               mmol/L
  from        to                              from        to                               from      to
  57,96    59,56             3.6              98,21    99,81              6.1             138,46 140,06              8.6
  59,57    61,17             3.7              99,82 101,42                6.2             140,07 141,67              8.7
  61,18    62,78             3.8             101,43 103,03                6.3             141,68 143,28              8.8
  62,79    64,39             3.9             103,04 104,64                6.4             143,29 144,89              8.9
  64,40    66,00             4.0             104,65 106,25                6.5             144,90 146,50              9.0
  66,01    67,61             4.1             106,26 107,86                6.6             146,51 148,11              9.1
  67,62    69,22             4.2             107,87 109,47                6.7             148,12 149,72              9.2
  69,23    70,83             4.3             109,48 111,08                6.8             149,73 151,33              9.3
  70,84    72,44             4.4             111,09 112,69                6.9             151,34 152,94              9.4
  72,45    74,05             4.5             112,70 114,30                7.0             152,95 154,55              9.5
  74,06    75,66             4.6             114,31 115,91                7.1             154,56 156,16              9.6
  75,67    77,27             4.7             115,92 117,52                7.2             156,17 157,77              9.7
  77,28    78,88             4.8             117,53 119,13                7.3             157,78 159,38              9.8
  78,89    80,49             4.9             119,14 120,74                7.4             159,39 160,99              9.9
  80,50    82,10             5.0             120,75 122,35                7.5             161,00 162,60              10.0
  82,11    83,71             5.1             122,36 123,96                7.6             162,61 164,21              10.1
  83,72    85,32             5.2             123,97 125,57                7.7             164,22 165,82              10.2
  85,33    86,93             5.3             125,58 127,18                7.8             165,83 167,43              10.3
  86,94    88,54             5.4             127,19 128,79                7.9             167,44 169,04              10.4
  88,55    90,15             5.5             128,80 130,40                8.0             169,05 170,65              10.5
  90,16    91,76             5.6             130,41 132,01                8.1             170,66 172,26              10.6
  91,77    93,37             5.7             132,02 133,62                8.2             172,27 173,87              10.7
  93,38    94,98             5.8             133,63 135,23                8.3             173,88 175,48              10.8
  94,99    96,59             5.9             135,24 136,84                8.4             175,49 177,09              10.9
  96,60    98,20             6.0             136,85 138,45                8.5             177,10 178,70              11.0




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                                                                                                instructions CRITICS

4.1.12        Alk. Phosphatase, AST (SGOT), ALT (SGPT), yGT, LDH should be reported in U/L. The following table can
through       be used to change mikrokat/L into U/L (to convert microkatal per liter to U/L, divide by 0,0167).
4.1.16
 ALP,AST,ALT,    ALP,AST,ALT,        ALP,AST,ALT, ALP,AST,ALT,                 ALP,AST,ALT,            ALP,AST,ALT,
   yGT, LDH         yGT, LDH           yGT, LDH           yGT, LDH                yGT, LDH               yGT, LDH
  mikrokat/L          U/L              mikrokat/L             U/L                 mikrokat/L                U/L
from       to                         from      to                         from       to
 0,067   0,084          5             0,902   0,919         55              1,737   1,754           105
 0,084   0,100          6             0,919   0,935         56              1,754   1,770           106
 0,100   0,117          7             0,935   0,952         57              1,770   1,787           107
 0,117   0,134          8             0,952   0,969         58              1,787   1,804           108
 0,134   0,150          9             0,969   0,985         59              1,804   1,820           109
 0,150   0,167          10            0,985   1,002         60              1,820   1,837           110
 0,167   0,184          11            1,002   1,019         61              1,837   1,854           111
 0,184   0,200          12            1,019   1,035         62              1,854   1,870           112
 0,200   0,217          13            1,035   1,052         63              1,870   1,887           113
 0,217   0,234          14            1,052   1,069         64              1,887   1,904           114
 0,234   0,251          15            1,069   1,086         65              1,904   1,921           115
 0,251   0,267          16            1,086   1,102         66              1,921   1,937           116
 0,267   0,284          17            1,102   1,119         67              1,937   1,954           117
 0,284   0,301          18            1,119   1,136         68              1,954   1,971           118
 0,301   0,317          19            1,136   1,152         69              1,971   1,987           119
 0,317   0,334          20            1,152   1,169         70              1,987   2,004           120
 0,334   0,351          21            1,169   1,186         71              2,004   2,021           121
 0,351   0,367          22            1,186   1,202         72              2,021   2,037           122
 0,367   0,384          23            1,202   1,219         73              2,037   2,054           123
 0,384   0,401          24            1,219   1,236         74              2,054   2,071           124
 0,401   0,418          25            1,236   1,253         75              2,071   2,088           125
 0,418   0,434          26            1,253   1,269         76              2,088   2,104           126
 0,434   0,451          27            1,269   1,286         77              2,104   2,121           127
 0,451   0,468          28            1,286   1,303         78              2,121   2,138           128
 0,468   0,484          29            1,303   1,319         79              2,138   2,154           129
 0,484   0,501          30            1,319   1,336         80              2,154   2,171           130
 0,501   0,518          31            1,336   1,353         81              2,171   2,188           131
 0,518   0,534          32            1,353   1,369         82              2,188   2,204           132
 0,534   0,551          33            1,369   1,386         83              2,204   2,221           133
 0,551   0,568          34            1,386   1,403         84              2,221   2,238           134
 0,568   0,585          35            1,403   1,420         85              2,238   2,255           135
 0,585   0,601          36            1,420   1,436         86              2,255   2,271           136
 0,601   0,618          37            1,436   1,453         87              2,271   2,288           137
 0,618   0,635          38            1,453   1,470         88              2,288   2,305           138
 0,635   0,651          39            1,470   1,486         89              2,305   2,321           139
 0,651   0,668          40            1,486   1,503         90              2,321   2,338           140
 0,668   0,685          41            1,503   1,520         91              2,338   2,355           141
 0,685   0,701          42            1,520   1,536         92              2,355   2,371           142
 0,701   0,718          43            1,536   1,553         93              2,371   2,388           143
 0,718   0,735          44            1,553   1,570         94              2,388   2,405           144
 0,735   0,752          45            1,570   1,587         95              2,405   2,422           145
 0,752   0,768          46            1,587   1,603         96              2,422   2,438           146
 0,768   0,785          47            1,603   1,620         97              2,438   2,455           147
 0,785   0,802          48            1,620   1,637         98              2,455   2,472           148
 0,802   0,818          49            1,637   1,653         99              2,472   2,488           149
 0,818   0,835          50            1,653   1,670         100             2,488   2,505           150
 0,835   0,852          51            1,670   1,687         101             2,505   2,522           151
 0,852   0,868          52            1,687   1,703         102             2,522   2,538           152
 0,868   0,885          53            1,703   1,720         103             2,538   2,555           153
 0,885   0,902          54            1,720   1,737         104             2,555   2,572           154

                                                                                                            7 of 15
                                                                                 instructions CRITICS

ALP,AST,ALT,     ALP,AST,ALT,   ALP,AST,ALT,    ALP,AST,ALT,   ALP,AST,ALT,     ALP,AST,ALT,
 yGT, LDH         yGT, LDH       yGT, LDH        yGT, LDH       yGT, LDH         yGT, LDH
 mikrokat/L          U/L         mikrokat/L         U/L         mikrokat/L           U/L
from       to                   from      to                   from       to
 2,572   2,589       155        3,440   3,457       207         4,309   4,325        259
 2,589   2,605       156        3,457   3,474       208         4,325   4,342        260
 2,605   2,622       157        3,474   3,490       209         4,342   4,359        261
 2,622   2,639       158        3,490   3,507       210         4,359   4,375        262
 2,639   2,655       159        3,507   3,524       211         4,375   4,392        263
 2,655   2,672       160        3,524   3,540       212         4,392   4,409        264
 2,672   2,689       161        3,540   3,557       213         4,409   4,426        265
 2,689   2,705       162        3,557   3,574       214         4,426   4,442        266
 2,705   2,722       163        3,574   3,591       215         4,442   4,459        267
 2,722   2,739       164        3,591   3,607       216         4,459   4,476        268
 2,739   2,756       165        3,607   3,624       217         4,476   4,492        269
 2,756   2,772       166        3,624   3,641       218         4,492   4,509        270
 2,772   2,789       167        3,641   3,657       219         4,509   4,526        271
 2,789   2,806       168        3,657   3,674       220         4,526   4,542        272
 2,806   2,822       169        3,674   3,691       221         4,542   4,559        273
 2,822   2,839       170        3,691   3,707       222         4,559   4,576        274
 2,839   2,856       171        3,707   3,724       223         4,576   4,593        275
 2,856   2,872       172        3,724   3,741       224         4,593   4,609        276
 2,872   2,889       173        3,741   3,758       225         4,609   4,626        277
 2,889   2,906       174        3,758   3,774       226         4,626   4,643        278
 2,906   2,923       175        3,774   3,791       227         4,643   4,659        279
 2,923   2,939       176        3,791   3,808       228         4,659   4,676        280
 2,939   2,956       177        3,808   3,824       229         4,676   4,693        281
 2,956   2,973       178        3,824   3,841       230         4,693   4,709        282
 2,973   2,989       179        3,841   3,858       231         4,709   4,726        283
 2,989   3,006       180        3,858   3,874       232         4,726   4,743        284
 3,006   3,023       181        3,874   3,891       233         4,743   4,760        285
 3,023   3,039       182        3,891   3,908       234         4,760   4,776        286
 3,039   3,056       183        3,908   3,925       235         4,776   4,793        287
 3,056   3,073       184        3,925   3,941       236         4,793   4,810        288
 3,073   3,090       185        3,941   3,958       237         4,810   4,826        289
 3,090   3,106       186        3,958   3,975       238         4,826   4,843        290
 3,106   3,123       187        3,975   3,991       239         4,843   4,860        291
 3,123   3,140       188        3,991   4,008       240         4,860   4,876        292
 3,140   3,156       189        4,008   4,025       241         4,876   4,893        293
 3,156   3,173       190        4,025   4,041       242         4,893   4,910        294
 3,173   3,190       191        4,041   4,058       243         4,910   4,927        295
 3,190   3,206       192        4,058   4,075       244         4,927   4,943        296
 3,206   3,223       193        4,075   4,092       245         4,943   4,960        297
 3,223   3,240       194        4,092   4,108       246         4,960   4,977        298
 3,240   3,257       195        4,108   4,125       247         4,977   4,993        299
 3,257   3,273       196        4,125   4,142       248         4,993   5,010        300
 3,273   3,290       197        4,142   4,158       249         5,010   5,027        301
 3,290   3,307       198        4,158   4,175       250         5,027   5,043        302
 3,307   3,323       199        4,175   4,192       251         5,043   5,060        303
 3,323   3,340       200        4,192   4,208       252         5,060   5,077        304
 3,340   3,357       201        4,208   4,225       253         5,077   5,094        305
 3,357   3,373       202        4,225   4,242       254         5,094   5,110        306
 3,373   3,390       203        4,242   4,259       255         5,110   5,127        307
 3,390   3,407       204        4,259   4,275       256         5,127   5,144        308
 3,407   3,424       205        4,275   4,292       257         5,144   5,160        309
 3,424   3,440       206        4,292   4,309       258         5,160   5,177        310


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                                                                                                                      instructions CRITICS



4. LABORATORY TESTS
 4.1.20.2       Amendment 4: urinary dipstick for protein also allowed




5. PHYSICAL EXAMINATION
 5.1        Amendment 4: Date of examination to be performed within 6 weeks after histological diagnosis.
 5.2        World Health Organisation (WHO) Performance Status. Patients with WHO > 2 are ineligible.
            0          Fully active; able to carry on all pre-disease performance (normal activity) without restriction.
            1          Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature.
            2          Ambulatory & capable of all self-care but unable to carry out any work activities; up and about > 50% of waking hours.
            3          Capable of only limited self-care; confined to bed or chair more than 50% of waking hours.
            4          Completely disabled; cannot carry on any self-care; totally confined to bed or chair.
            5          Dead.
 5.8        Insertion of a jenunostomy during surgery is strongly recommended. It should be left in situ until postoperative
            chemo(radiation) is completed.




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                                                                                                                   instructions CRITICS
F03      PREOPERATIVE CHEMOTHERAPY FORM

If none of the preoperative courses were given please do not forget to tick no for the item chemotherapy started and reason
not started on top of page one!



 2.2      World Health Organisation (WHO) Performance Status. Patients with WHO > 2 are ineligible.
          0         Fully active; able to carry on all pre-disease performance (normal activity) without restriction.
          1         Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature.
          2         Ambulatory & capable of all self-care but unable to carry out any work activities; up and about > 50% of waking hours.
          3         Capable of only limited self-care; confined to bed or chair more than 50% of waking hours.
          4         Completely disabled; cannot carry on any self-care; totally confined to bed or chair.
          5         Dead.
 2.4      BSA = Body Surface Area
 4        For Dutch centers: cisplatin
          For Swedish centers: oxaliplatin
 8        New item: Investigations before start of course 3 to exclude progressive disease




F04      SURGERY FORM

If no surgery at all has taken place please do not forget to complete page one of this form. Fill out or write not done for the
preoperative investigations and laboratory tests. On the second page please tick none for the type of gastrectomy (3.6) and
sign and date the form on the third page!




 1.6      ASA Classification = American Society of Anesthesiologists Classification. Patients with ASA > 3 should not be
          operated.
          1         Generally healthy, localized pathologic process
          2         Stable mild to moderate systemic condition (eg, smoker, HTN, obesity, PG, DM, asthma, >70)
          3         Moderately severe systemic disorder (eg, poorly controlled disorders, hx of CAD, dysrhythmia)
          4         Severe and clearly life-threatening disorder (eg, recent MI, unstable angina, severe CHF or COPD, hepatic or renal
                    failure)
          5         Little chance of survival; procedure performed in desperation.


 3.3.1    Time at which specimen was removed from the abdomen.
                                                                              +
 3.7      Type of Lymph Node Dissection: D1 has been changed in D1
 3.17     Jejunostomy is obligatory.




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                                                                                                             instructions CRITICS
F05      PATHOLOGY FORM

 1.2.1     Time when fresh specimen was sampled and put in freezer
 1.13      pCR = pathologic Complete Response
 1.22      Macroscopic involvement of the wall of veins (with no tumour within the veins) is classified as V2
 1.26      A tumour may penetrate muscularis propria with extension into the gastrocolic or gastrohepatic ligaments or
           the greater and lesser omentum without perforation of the visceral peritoneum covering these structures. In
           this case, the tumour is classified as T2. If there is perforation of the visceral peritoneum covering the gastric
           ligaments or omenta, the tumour is classified as T3.
           The adjacent structures of the stomach are the spleen, transverse colon, liver, diaphragm, pancreas,
           abdominal wall, adrenal gland, kidney, small intestine, and retroperitoneum.
           Intramural extension to the duodenum or oesophagus is classified by the depth of the greatest invasion in any
           of these sites including stomach
           pT0      no histological evidence of primary tumour
           pTis     carc. in situ: intraepithelial tumour without invasion of lamina propria
           pT1      tumour invades lamina propria or submucosa
           pT2a     tumour invades muscularis propria
           pT2b     tumour invades subserosa
           pT3      tumour penetrates serosa (visceral peritoneum) without invasion of adjacent structures
           pT4      tumour invades adjacent structures
           pTx      primary tumour cannot be assessed histologically

 1.27      Histological examination of a regional lymphadenectomy specimen will ordinarily include 15 or more lymph
           nodes. If the lymph nodes are negative, but the number ordinarily examined is not met, classify as pN0.
           The regional lymph nodes of the stomach are the perigastric nodes along the lesser and greater curvatures,
           the nodes along the left gastric, common hepatic, splenic, and coeliac arteries, and the hepatoduodenal
           nodes.
           The regional lymph nodes of the gastroesophageal junction are the paracardial, left gastric, coeliac,
           diaphragmatic, and the lower mediastinal paraoesophageal.
           pN0      no regional lymph nodes histologically
           pN1      metastasis in 1 - 6 regional lymph nodes
           pN2      metastasis in 7 - 15 regional lymph nodes
           pN3      metastasis in >16 regional lymph nodes
           pNx      regional lymph nodes cannot be assessed histologically




 1.28      Involvement of other intra-abdominal nodes such as retropancreatic, mesenteric, and para-aortic is classified
           as distant metastases
           M0       no distant metastases
           M1       distant metastasis
           Mx       distant metastases cannot be assessed
Please send CRF page together with anonimised copies of pathology reports.

                                                                                                                        11 of 15
                                                                                                                   instructions CRITICS
F06a POSTOPERATIVE CHEMOTHERAPY FORM

If none of the postoperative courses were given please do not forget to tick no for the item chemotherapy started and reason
not started on top of page one!




 2.2      World Health Organisation (WHO) Performance Status. Patients with WHO > 2 are ineligible.
          0         Fully active; able to carry on all pre-disease performance (normal activity) without restriction.
          1         Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature.
          2         Ambulatory & capable of all self-care but unable to carry out any work activities; up and about > 50% of waking hours.
          3         Capable of only limited self-care; confined to bed or chair more than 50% of waking hours.
          4         Completely disabled; cannot carry on any self-care; totally confined to bed or chair.
          5         Dead.
 2.4      BSA = Body Surface Area
 3.3      The question delay next cycle after course 6 is skipped in version 3.0. This question is obviously not applicable.
          Please fill in 0 for this question in the CRF versions 1 and 2.
 4                        Amendment 3: For Dutch centers: cisplatinFor Swedish centers: oxaliplatin
 4.3      The question delay next cycle after course 6 is skipped in version 3.0. This question is obviously not applicable.
          Please fill in 0 for this question in the CRF versions 1 and 2.




F06b POSTOPERATIVE CHEMORADIATION FORM

If none of the postoperative courses were given please do not forget to tick no for the item chemotherapy started and reason
not started on top of page one!



 2.2      World Health Organisation (WHO) Performance Status. Patients with WHO > 2 are ineligible.
          0         Fully active; able to carry on all pre-disease performance (normal activity) without restriction.
          1         Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature.
          2         Ambulatory & capable of all self-care but unable to carry out any work activities; up and about > 50% of waking hours.
          3         Capable of only limited self-care; confined to bed or chair more than 50% of waking hours.
          4         Completely disabled; cannot carry on any self-care; totally confined to bed or chair.
          5         Dead.
 2.4      BSA = Body Surface Area
 3        Amendment 3: For Dutch centers: cisplatin
                          For Swedish centers: oxaliplatin
 3.4      The question delay next cycle after week 5 is skipped in version 3.1. This question is obviously not applicable.
          Please fill in 0 for this question in the CRF versions 2 and 3.
 4.7      The question delay next cycle after week 5 is skipped in version 3.1. This question is obviously not applicable.
          Please fill in 0 for this question in the CRF versions 2 and 3.




F07 POSTOPERATIVE RADIOTHERAPY FORM

If no radiotherapy was given please do not forget to tick no for the item radiotherapy started and reason radiotherapy not
started on top of the page!




                                                                                                                                 12 of 15
                                                                                                         instructions CRITICS
F08      ADVERSE EVENT FORM

Complete:
  AEs related or not related to study treatment
  AEs during follow-up if event is possibly related to treatment


          For 3x ECC (EOC) + surgery + 45 Gy + 5w CC (OC) (experimental arm):
          use during preoperative period for the cycle/week number the values 1 through 3
 2
          use during postoperative period for the cycle/week number the values 1 through 5


          For 3x ECC (EOC) + surgery + 3x ECC (EOC) (control arm):
          use during preoperative period for the cycle/week number the values 1 through 3
 2
          use during postoperative period for the cycle/week number the values 4 through 6




Use NCI CTCAE version 3.0 and use 0 in the Grade, if no toxicity was present. Report the worst grading during each
cycle.

An adverse event is defined as any untoward medical occurrence in a subject to whom a drug has been administrated; the
event does not need to have a causal relationship to the study drug(s). All such medical occurrences from the time the subject
signs the informed consent to 30 days after the last dose of study drug(s) or until the start of other anti-cancer treatment,
whichever comes first, are reported as adverse events and must be recorded on this CRF.

All adverse events deemed possible related to study will be followed until resolution (or the Investigator assesses them to be
chronic or stable) or initiation of other anti-cancer therapy, whatever occurs first.

In addition, any known untoward event that occurs subsequent to the adverse event reporting period that the investigator
assesses as possibly related to the study drug should also be considered as an adverse event. A pre-existing condition
should not be reported as an adverse event unless the condition worsens or episodes increase in frequency during the
adverse event reporting period. Symptoms of the targeted cancer should not be reported as adverse events.

Adverse events will be reviewed using the National Cancer Institute Common Toxicity Criteria (NCI CTC) (see protocol). Any
adverse event occurred but not categorised by the NCI CTC should be graded by the physician and be recorded on the case
report form using a scale of
    1. Mild                        Does not interfere with subject's usual function.
    2. Moderate                    Interferes to some extent with subject's usual function.
    3. Severe                      Interferes significantly with subject's usual function.
    4. Life threatening            Resulting in risk of death, organ damage or disability.
    5. Fatal                       Fatal.

Note the distinction between the gravity and the intensity of an adverse event. Severe is a measure of intensity; thus a severe
reaction is not necessarily a serious reaction. For example, a headache may be severe in intensity, but would not be
classified as serious unless it met one of the criteria that define serious events.




F09      END OF STUDY TREATMENT FORM

Should only be completed when patient stops study treatment (completed protocol treatment, progressive disease etc.).
In these cases patient will still be followed up!




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                                                                                                        instructions CRITICS
F10      FOLLOW-UP FORMS

It is important to comply with the follow-up schedule: the month at the CRF should correspond with the time since completion
adjuvant therapy. If a visit is skipped, fill in not done. For each visit, a window according to the next schedule is allowed.


          Month 1           window until 1.5 months after completion
          Month 2           window from 1.5 until 2.5 months after completion
          Month 3           window from 2.5 until 4.5 months after completion
          Month 6           window from 4.5 until 7.5 months after completion
          Month 9           window from 7.5 until 10.5 months after completion
          Month 12          window from 10.5 until 15 months after completion
          Month 18          window from 15 until 21 months after completion
          Month 24          window from 21 until 27 months after completion
          Month 30          window from 27 until 33 months after completion
          Month 36          window from 33 until 39 months after completion
          Month 42          window from 39 until 45 months after completion
          Month 48          window from 45 until 51 months after completion
          Month 54          window from 51 until 57 months after completion
          Month 60          window from 57 until 63 months after completion


 6.1      Please specify if abnormal physical examination.
 10.      A pre-existing condition should not be reported as an adverse event (AE) unless the condition worsens or episodes
          increase in frequency during the AE reporting period. Symptoms of the targeted cancer should not be reported as
          AEs.




F11      RECURRENCE / NEW PRIMARY FORM
 1.       For every separate occurrence of an event (locoregional recurrence, distant metastases or new primary tumour),
          please fill out a Recurrence / New Primary Form.
          Fill in the date of the first evidence of the recurrence/new primary.
          For new primary: report any new primary cancer

 1.1      A locoregional recurrence is a recurrence in (histological or cytological proof required):
              Original location (gastric stump)
              Anastomosis
              Regional lymph nodes
              Adjacent organ

 1.2      Distant metastases are metastases beyond the locoregional area (histological or cytological proof is preferred,
          especially in solitary lesions):
             Lymph nodes not included in the loco regional areas
             Skin
             Liver (multiple nodules on liver ultrasound or CT-scan are acceptable without pathological correlation)
             Lung (multiple nodules on chest X-ray are acceptable without pathological correlation)
             Bone (positive bone scans must be correlated with bone X-ray. Multiple lytic or blastic lesions or multiple
              hotspots on the bone scan are acceptable without pathological correlation)
             Central nervous system
             Soft tissue
             Other sites not defined above (e.g. spleen, kidney)

 1.4.     No new primary tumour is non-melanoma skin cancer and in-situ carcinoma of the cervix.


Please send CRF page together with anonimised copies of relevant reports and letters.




                                                                                                                    14 of 15
                                                                                                            instructions CRITICS
F12      OFF STUDY FORM

Should be filled out when patient/investigator decides to stop the study. No further follow-up is needed.
Also fill out the form when a patient has died.




F20      DEATH FORM

If the death is (possibly) related to the study medication, please report an Adverse Event Form and a Serious Adverse
Event Form, in the treatment and in post-treatment period.




F40      SERIOUS ADVERSE EVENT FORM

A Serious Adverse Event (SAE):
    Is fatal or life-threatening (i.e. results in an immediate risk of death)
    Is permanently or substantially disabling
    Requires prolonged hospitalisation (only if related to an unexpected complication)
    Is a new cancer (other then stomach cancer)
    Is a medication overdose

The following events are not considered as an SAE:
    Recurrences. For recurrences, the CRF “recurrence/new primary” has to be filled in
    Death due to progression of disease

This category also includes any other event the Investigator judges to be serious or which would suggest a significant hazard,
contra-indication, side effect or precaution.




F50      COMMENT FORM

Do not write comments on CRF pages, unless there is a “note item”. Please do write comments on this special Comment
Form.

Please, send this form to the Central Datacenter in Leiden after the form is filled. Use a new Comment Form for further
comments. In case of corrections in data on other forms, please send immediately.




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