S0220 Phase II Intergroup
Coordinating Group: SWOG
A Phase II Trial of Induction Chemoradiotherapy with Cispatin/Etoposide
Followed by Surgical Resection, Followed by Docetaxel for Non-Small Cell
Lung Cancer Involving the Superior Sulcus (Pancoast Tumors)
Intergroup Participants: Date Activated:
SWOG, ACOSOG, CALGB, ECOG, 7/1/2003
NCCTG, NCIC CTG
Study Coordinators:
M Kraut, J Sonett, C Thomas, V Rusch (ACOSOG),
J Jett (NCCTG), H Gillenwater (ECOG),
A Lyss (CALGB), S Laurie (NCIC CTG)
Statisticians:
J Moon, J Crowley
Data Coordinator:
L Kaye
Schema
R Local or distant
Off protocol treatment
E R progression
G E
I CDDP E
S V
+
T A R R
VP-16
R L E E
A + U Docetaxel
G Surgery G
T XRT A X 3 cycles
I T 2 3
O E No distant mets
N No local
R
progression E
Refuse or G Docetaxel
medically unfit X 3 cycles
for surgery 3
Objectives To investigate in an exploratory manner the asso-
To assess the feasibility of administrating a regi- ciation of p27, TUBB-III and Map4 expression
men of cisplatin and etoposide concurrent with a levels with patient responses and outcomes.
program of fractionated chest radiation followed
Patient Population
by surgical resection and consolidation chemo-
Patients must have histologic or cytologic proof
therapy with docetaxel in patients with Pancoast
of a newly diagnosed non-small cell lung carci-
tumors without mediastinal or supraclavicular noma with involvement of the superior sulcus
nodal involvement. (T3-4, N0-1). Disease must be documented by
To assess overall survival, time to progression, both a chest X-ray and a CT scan. Patients with
response (confirmed plus unconfirmed, complete mediastinal or supraclavicular nodal involvement
plus partial during induction), resectability rates (N2-3), two or more parenchymal lesions, or dis-
and toxicity in this patient population treated with tant metastases (including malignant pleural effu-
this regimen. sions) are ineligible.
OCTOBER 4 - 7, 2007 SOUTHWEST ONCOLOGY GROUP LUNG 8
S0220/II
Mediastinal exploration is required to establish Summary Statement
eligibility. Patients must not have had prior thora- As of June 30, 2007, 45 patients have been regis-
cotomy for purposes other than diagnosis or stag- tered. One patient refused protocol treatment and
ing. Patients must not have had any prior chemo- is not analyzable. Twenty-nine patients have pro-
therapy or radiotherapy for lung cancer. ceeded to the surgery step and 19 patients have
been registered to the consolidation step.
All patients must have adequate hematologic, he-
patic, renal, cardiac, and pulmonary function, and Thirty-nine patients have been evaluated for ad-
they must be a candidate for potential future pul- verse events related to concurrent chemoradio-
monary resection as determined by the attending therapy. There has been one treatment-related
thoracic surgeon. Patients with clinical hearing death due to infection with Grade 3-4 neutro-
loss must be willing to accept the potential for penia. Seven additional patients (18%) have ex-
worsening of symptoms. Patients with sympto- perienced Grade 4 adverse events, primarily he-
matic peripheral neuropathy, pericardial effu- matologic. Eighteen patients have been evaluated
sions, or superior vena cava syndrome are ineli- for surgical adverse events. Six patients (33%)
gible. All patients must have a Zubrod perform- were reported as having Grade 3 adverse events
ance status of 0, 1 or 2; those patients with a per- related to surgery. Fifteen patients have been as-
formance status of 2 must also meet additional sessed for adverse events related to consolidation
requirements regarding liver function and weight chemotherapy. Four patients (27%) have experi-
loss. enced Grade 4 adverse events.
Accrual Goals
This study will accrue 45 eligible patients.
Initial Registrations By 3 Month Intervals
10
8
6 6
5
3 3
2 2 2 2 2 2
1 1
0
JAN APR JUL OCT JAN APR JUL OCT JAN APR JUL OCT JAN APR
MAR JUN SEP DEC MAR JUN SEP DEC MAR JUN SEP DEC MAR JUN
2004 2004 2004 2004 2005 2005 2005 2005 2006 2006 2006 2006 2007 2007
Time of Registration
CDDP, VP-16/RT
OCTOBER 4 - 7, 2007 SOUTHWEST ONCOLOGY GROUP LUNG 9
S0220/II
Registration by Institution
Concurrent Chemoradiotherapy
Registrations ending June 30, 2007
Total Total
Institutions Reg Institutions Reg
NCCTG 8 Colorado, U of 1
NCIC 7 Columbia River CCOP 1
ACOSOG 5 ECOG 1
CALGB 4 Grand Rapids CCOP 1
Cincinnati MC, U of 3 Kansas City CCOP 1
Michigan CRC CCOP 3 Loyola University 1
Montana CCOP 2 New Mexico MBCCOP 1
Puget Sound 2 Southeast CCC CCOP 1
Beaumont CCOP 1 Wichita CCOP 1
City of Hope Med Ctr 1 Total (19 Institutions) 45
Registration, Eligibility, and Evaluability
Concurrent Chemoradiotherapy
Registrations ending June 30, 2007; Data as of July 13, 2007
CDDP, CDDP,
VP-16/RT VP-16/RT
NUMBER REGISTERED 45 RESPONSE ASSESSMENT
ELIG./ PEND. ELIG. 45 Determinable 26
Analyzable, Pend. Elig. 3 Not Determinable 2
Not Analyzable 1 Too Early 5
Not Applicable 11
BASELINE DISEASE STATUS
Measurable 31 ADVERSE EVENT ASSESSMENT
Non Measurable 11 Evaluable 39
Too Early 2 Too Early 5
Patient Characteristics
Concurrent Chemoradiotherapy
Registrations ending June 30, 2007; Data as of July 13, 2007
CDDP, VP-16/RT CDDP, VP-16/RT
(n=44) (n=44)
AGE HISPANIC
Median 59.7 No 41 93%
Minimum 44.0 Unknown 3 7%
Maximum 75.1
RACE
SEX White 40 91%
Males 31 70% Asian 3 7%
Females 13 30% Native American 1 2%
OCTOBER 4 - 7, 2007 SOUTHWEST ONCOLOGY GROUP LUNG 10
S0220/II
Treatment Summary
Concurrent Chemoradiotherapy
Registrations ending June 30, 2007; Data as of July 13, 2007
CDDP,
VP-16/RT
NUMBER ON PROTOCOL TREATMENT 6
NUMBER OFF PROTOCOL TREATMENT 38
REASON OFF TREATMENT
Treatment completed as planned 30
Adverse Events or side effects 2
Refusal unrelated to adverse events 1
Progression/relapse 3
Death 0
Other - not protocol specified 0
Reason under review 2
MAJOR PROTOCOL DEVIATIONS 0
Number of Patients with a Given Type and Grade of Adverse Event
Concurrent Chemoradiotherapy
Adverse Events Unlikely or Not Related to Treatment Excluded
Registrations ending June 30, 2007; Data as of July 13, 2007
CDDP, VP-16/RT CDDP, VP-16/RT
(n=39) (n=39)
Grade Grade
ADVERSE EVENT Unk 0 1 2 3 4 5 ADVERSE EVENT Unk 0 1 2 3 4 5
ALT 0 35 2 2 0 0 0 Insomnia 0 38 0 1 0 0 0
AST 0 36 3 0 0 0 0 Leukocytes 0 18 6 3 9 3 0
Alkaline phosphatase 0 38 1 0 0 0 0 Lung Inf, 3-4 ANC: bronchus 0 38 0 0 1 0 0
Allergic reaction 0 38 0 0 0 1 0 Lung Pain: throat/phar/lar 0 38 0 1 0 0 0
Alopecia 0 29 5 5 0 0 0 Lymphopenia 0 35 0 1 2 1 0
Anorexia 0 33 6 0 0 0 0 Memory impairment 0 38 1 0 0 0 0
Bilirubin 0 38 1 0 0 0 0 Metabolic/Lab-other 0 37 1 0 1 0 0
Burn 0 38 1 0 0 0 0 Mood alteration: agitation 0 38 0 1 0 0 0
Constipation 0 30 8 1 0 0 0 Mood alteration: depression 0 38 0 1 0 0 0
Creatinine 0 37 2 0 0 0 0 Mucositis, clin: esophagus 0 38 0 0 1 0 0
Dehydration 0 33 4 0 1 1 0 Mucositis, clin: oral cavity 0 35 3 1 0 0 0
Diarrhea 0 32 3 3 1 0 0 Mucositis, funct: oral cav. 0 37 1 1 0 0 0
Dizziness 0 37 2 0 0 0 0 Mucositis, funct: pharynx 0 37 1 1 0 0 0
Dry skin 0 38 1 0 0 0 0 Musculo. Pain: joint 0 38 0 1 0 0 0
Dysphagia 0 37 1 1 0 0 0 Musculo. Pain: limb 0 38 1 0 0 0 0
Dyspnea 0 38 1 0 0 0 0 Musculo. Pain: muscle 0 38 0 1 0 0 0
Edema-limb 0 38 1 0 0 0 0 Nail changes 0 38 1 0 0 0 0
Esophagitis 1 30 4 3 1 0 0 Nasal/paranasal reactions 0 38 1 0 0 0 0
Fatigue 0 11 15 11 2 0 0 Nausea 0 11 19 8 1 0 0
Febrile neutropenia 0 37 0 0 1 1 0 Neuropathy-sensory 0 34 4 1 0 0 0
Fever 0 37 2 0 0 0 0 Neutrophils 0 21 0 4 9 5 0
Flushing 0 38 1 0 0 0 0 Pain-other 0 36 2 1 0 0 0
GI Pain: abdomen 0 38 0 1 0 0 0 Platelets 0 27 9 3 0 0 0
GI-other 0 35 3 1 0 0 0 Prolapse stoma, GI 0 31 5 3 0 0 0
GU Inf, Unk ANC: UTI 0 38 0 1 0 0 0 RT Dermatitis: ChemoRT derm. 0 38 1 0 0 0 0
GU Pain: bladder 0 38 1 0 0 0 0 RT Dermatitis: RT dermatitis 0 25 11 3 0 0 0
Gastritis 0 37 2 0 0 0 0 Rigors/chills 0 35 4 0 0 0 0
Hearing (w/o monit. prog.) 0 38 0 1 0 0 0 Supra Arrhyth: NOS 0 38 1 0 0 0 0
Hemoglobin 0 16 15 5 3 0 0 Supra Arrhyth: Sinus Brady. 0 38 1 0 0 0 0
Hiccoughs 0 38 0 1 0 0 0 Sweating 0 38 0 1 0 0 0
Hot flashes 0 38 1 0 0 0 0 Taste alteration 0 27 8 4 0 0 0
Hyperglycemia 0 38 1 0 0 0 0 Thrombosis/embolism 0 38 0 0 0 1 0
Hypoalbuminemia 0 35 2 2 0 0 0 Voice changes 0 37 2 0 0 0 0
Hypocalcemia 0 38 0 1 0 0 0 Vomiting 0 25 7 5 2 0 0
Hypokalemia 0 38 1 0 0 0 0 Weight Loss 0 30 6 3 0 0 0
Hypomagnesemia 0 38 1 0 0 0 0 Weight gain 0 38 1 0 0 0 0
Hyponatremia 0 34 4 0 1 0 0
Hypotension 0 36 2 1 0 0 0 MAXIMUM GRADE
Inf, 3-4 ANC: blood 0 38 0 0 0 0 1 ANY ADVERSE EVENT
Infection-other 0 38 1 0 0 0 0 Number 0 0 9 11 11 7 1
OCTOBER 4 - 7, 2007 SOUTHWEST ONCOLOGY GROUP LUNG 11
S0220/II
Registration, Eligibility, and Evaluability
Surgery
Registrations ending June 30, 2007; Data as of July 13, 2007
Surgery Surgery
NUMBER REGISTERED 29 ADVERSE EVENT ASSESSMENT
ELIG./ PEND. ELIG. 29 Evaluable 18
Analyzable, Pend. Elig. 3 Too Early 11
Patient Characteristics
Surgery
Registrations ending June 30, 2007; Data as of July 13, 2007
Surgery Surgery
(n=29) (n=29)
AGE HISPANIC
Median 61.6 No 27 93%
Minimum 44.6 Unknown 2 7%
Maximum 75.3
RACE
SEX White 26 90%
Males 22 76% Asian 2 7%
Females 7 24% Native American 1 3%
Number of Patients with a Given Type and Grade of Adverse Event
Surgery
Adverse Events Unlikely or Not Related to Treatment Excluded
Registrations ending June 30, 2007; Data as of July 13, 2007
Surgery Surgery
(n=18) (n=18)
Grade Grade
ADVERSE EVENT 0 1 2 3 4 5 ADVERSE EVENT 0 1 2 3 4 5
Creatinine 16 2 0 0 0 0 Lung Pain: chest wall 16 0 1 1 0 0
Fatigue 17 0 1 0 0 0 Musculo. Pain: bone 17 0 1 0 0 0
Fever 14 1 3 0 0 0 Musculo. Pain: limb 17 0 0 1 0 0
Hemoglobin 9 3 3 3 0 0 Neuropathy-sensory 16 0 2 0 0 0
Hyperglycemia 16 2 0 0 0 0 Platelets 15 3 0 0 0 0
Hypocalcemia 17 1 0 0 0 0 Pneumothorax 15 2 1 0 0 0
Hypokalemia 17 1 0 0 0 0 Supra Arrhyth: Atrial Fib. 17 0 1 0 0 0
Hypomagnesemia 17 1 0 0 0 0 Supra Arrhyth: Atrial Flut. 17 0 1 0 0 0
Hypophosphatemia 17 0 1 0 0 0 Supra Arrhyth: NOS 16 1 1 0 0 0
Hypotension 17 0 1 0 0 0 Supra Arrhyth: Sinus Tachy. 17 0 1 0 0 0
Hypoxia 16 0 0 2 0 0 Weight Loss 17 0 1 0 0 0
Leukocytes 17 1 0 0 0 0
Lung Inf, 3-4 ANC: lung 17 0 0 1 0 0 MAXIMUM GRADE ANY ADVERSE EVENT
Lung Inf, Unk ANC: lung 17 0 0 1 0 0 Number 2 3 7 6 0 0
Registration, Eligibility, and Evaluability
Consolidation Chemotherapy
Registrations ending June 30, 2007; Data as of July 13, 2007
Consolidation Consolidation
Chemotherapy Chemotherapy
NUMBER REGISTERED 19 ADVERSE EVENT ASSESSMENT
ELIG./ PEND. ELIG. 19 Evaluable 15
Analyzable, Pend. Elig. 3 Too Early 4
OCTOBER 4 - 7, 2007 SOUTHWEST ONCOLOGY GROUP LUNG 12
S0220/II
Patient Characteristics
Consolidation Chemotherapy
Registrations ending June 30, 2007; Data as of July 13, 2007
Consolidation Consolidation
Chemotherapy Chemotherapy
(n=19) (n=19)
AGE HISPANIC
Median 61.7 No 18 95%
Minimum 44.8 Unknown 1 5%
Maximum 74.8
RACE
SEX White 17 89%
Males 14 74% Asian 1 5%
Females 5 26% Native American 1 5%
Treatment Summary
Consolidation Chemotherapy
Registrations ending June 30, 2007; Data as of July 13, 2007
Consolidation
Chemotherapy
NUMBER ON PROTOCOL TREATMENT 4
NUMBER OFF PROTOCOL TREATMENT 15
REASON OFF TREATMENT
Treatment completed as planned 12
Adverse Events or side effects 1
Refusal unrelated to adverse events 0
Progression/relapse 0
Death 0
Other - not protocol specified 1
Reason under review 1
MAJOR PROTOCOL DEVIATIONS 0
OCTOBER 4 - 7, 2007 SOUTHWEST ONCOLOGY GROUP LUNG 13
S0220/II
Number of Patients with a Given Type and Grade of Adverse Event
Consolidation Chemotherapy
Adverse Events Unlikely or Not Related to Treatment Excluded
Registrations ending June 30, 2007; Data as of July 13, 2007
Consolidation Consolidation
Chemotherapy Chemotherapy
(n=15) (n=15)
Grade Grade
ADVERSE EVENT 0 1 2 3 4 5 ADVERSE EVENT 0 1 2 3 4 5
Alopecia 13 0 2 0 0 0 Lymphopenia 13 0 1 1 0 0
Constipation 13 2 0 0 0 0 Mood alteration: depression 14 1 0 0 0 0
Cough 13 1 1 0 0 0 Mucositis, funct: oral cav. 14 0 1 0 0 0
Dehydration 13 1 0 1 0 0 Mucositis, funct: pharynx 14 0 1 0 0 0
Diarrhea 11 2 2 0 0 0 Musculo. Pain: muscle 13 0 2 0 0 0
Dry skin 14 1 0 0 0 0 Nail changes 14 1 0 0 0 0
Dysphagia 14 1 0 0 0 0 Nausea 12 1 1 1 0 0
Dyspnea 13 0 0 2 0 0 Neuropathy-motor 14 1 0 0 0 0
Edema-head and neck 14 1 0 0 0 0 Neuropathy-sensory 10 4 1 0 0 0
Edema-limb 14 1 0 0 0 0 Neutrophils 9 0 0 3 3 0
Fatigue 6 4 4 1 0 0 Pain-other 14 0 0 1 0 0
Fever 13 0 2 0 0 0 Platelets 14 1 0 0 0 0
GI Pain: abdomen 14 0 1 0 0 0 Pleural effusion 13 0 2 0 0 0
GI-other 14 0 1 0 0 0 Pneumonitis 14 1 0 0 0 0
Gastritis 14 1 0 0 0 0 Prolapse stoma, GI 14 0 1 0 0 0
Hand-foot 13 0 2 0 0 0 Pruritus 14 0 1 0 0 0
Hemoglobin 6 5 4 0 0 0 Psychosis 14 0 1 0 0 0
Hyperglycemia 14 0 0 1 0 0 RT Dermatitis: RT dermatitis 14 1 0 0 0 0
Hypoalbuminemia 13 2 0 0 0 0 Rhinitis 14 0 1 0 0 0
Hypocalcemia 14 1 0 0 0 0 Supra Arrhyth: Sinus Tachy. 14 1 0 0 0 0
Hypokalemia 14 1 0 0 0 0 Taste alteration 13 1 1 0 0 0
Hypotension 14 1 0 0 0 0 Vomiting 13 0 1 1 0 0
Hypoxia 14 0 0 1 0 0 Watery eye 14 1 0 0 0 0
Leukocytes 8 1 2 3 1 0 Weight Loss 10 3 1 1 0 0
Lung Hemorrhage: resp. tract 14 0 1 0 0 0
Lung Inf, 3-4 ANC: lung 14 0 0 1 0 0 MAXIMUM GRADE ANY ADVERSE EVENT
Lung Inf, 3-4 ANC: sinus 14 0 1 0 0 0 Number 1 2 2 6 4 0
Lung Pain: chest wall 14 0 1 0 0 0
OCTOBER 4 - 7, 2007 SOUTHWEST ONCOLOGY GROUP LUNG 14
S0220/II