Newsletter 03
TRIAL
SUMMER NEWSLETTER
July 2004
Protocol Revised Version 2.2
You should by now have received the amended version of the RIB Protocol which is
Revised version 2.2 dated 30/01/2004.
Please destroy earlier versions and replace them with this one.
You will also receive with this newsletter the supporting documents for another
amendment to include a check in the consent form with regard to informing a patient’s GP
that they are participating in the study (Consent form version 2.3, dated 24th May 2004)
This will mean a new version number for the protocol – Revised version 2.3 Dated 02 July
2004. Further amendments are likely in the near future due to the EU Directive, so please
bear with us in this transition period.
Paperwork – a reminder…
Please return the entry form when you know the date of treatment in addition to a copy of
the randomisation form from your CRF booklet and also a copy of the consent form.
Please ensure that patients give the urine sample and complete the pain and quality of life
questionnaires on the day of treatment, then wait a week, call the patient for the acute
toxicity information (Section C of the treatment form), and then return the treatment form
as soon as possible.
New staff
We would like to welcome Sandrine Stefanidis who started on 7th June as the new Data
Manager for the RIB trial.
The EU Directive and RIB
The DDX for the RIB trial rolled over as a CTA on 1st May 2004. University College London
agreed to act as sponsor. The RIB trial team are working to bring all documents in line with
the Directive and will be providing an update on this in the future.
Recent queries
If patient has a corrected calcium of 2.71 are they eligible?
Depends. If the patient is symptomatic and you are intending to treat them for
hypercalcaemia then they are not eligible. Otherwise they are eligible.
Newsletter 03
th
Launch meeting 7 May
Thanks to all those who attended. It was a useful opportunity to get representatives from
participating centres together to discuss their experiences of running the trial in their
centres, and to ask questions. The issues discussed reflect many of those which were in
the progress questionnaire (see below).
Feeback from launch meeting
Patients can enter the trial if they have more than one site of metastases and/or more
that one site of pain provided that there is a single site that is more painful than the
others and you and the patient will focus on that single site of pain during the trial.
Making this clear to the patient on the day they complete the first questionnaire is very
important.
There were some concerns about taking consent and allowing patients time to reflect.
We would recommend that patients have at least 24 hours to consider the patient
information leaflet before signing consent, however the EU Directive does not impose a
minimum time. The most important considerations for patients is 1) that they have the
opportunity to ask questions and 2) they have time to decide.
As we routinely follow-up patients by phone for overdue forms – it would be really
useful if you let patients know that they may receive a call from the trials centre to
check up on overdue forms, and that a call would be only made once.
Results from the Progress Questionnaire
22
Number of centres who returned questionnaire
No. of
If potentially eligible patients have not been entered please centres
indicate why:
Patient presents with severe pain - want to treat them immediately 11
Patient has been on bisphosphonates in previous 6 months 8
Problems locally with radiotherapy bookings 1
Delays due to pharmacy -
No eligible patients to date 4
Any other local problems -
Are there any other reasons you would like to add that are not listed
above?
Patients presenting with multiple sites of pain
Patients has other complications or is too frail
Respondent has reservations that a single dose of RT is enough
Do you have any other comments?
Reported difficulty finding patients with solitary mets
Patients find it difficult to differentiate the target pain area with other aches and
pains - responses on questionnaire may be ‘clouded’
One centre indicated that a change in hormone therapy was also excluding
potential patients
This questionnaire was posted to all centres participating in the trial. If you have not
responded and would like a copy or would like to comment on your experiences of running
the trial at you hospital please call Orla or Sandrine on 020 7679 8036/8013.
F IG 1 . R IB T ria l A c c ru a l A p ril 2 0 0 3 - Ju n e 2 0 0 4 Newsletter 03
70
60
50
N o. of pa tie nts
40
N o o f p a tie n ts
30
20
10
0
ly
ay
ay
il
il
b
ne
ne
t
ch
y
er
r
r
r
us
pr
pr
Fe
be
ar
be
be
Ju
M
ob
M
ar
Ju
Ju
A
A
ug
nu
em
em
m
M
ct
A
te
Ja
O
ov
ec
ep
N
D
S
M o n th
We are hoping that as an outcome of the launch meeting research staff at hospitals and
NCRN managers will help us to ‘relaunch’ the trial at their centres in order to regenerate
interest and enthusiasm in the study. We are circulating trial summaries to main hospital
contacts to advertise the trial in an appropriate area of your hospital/office. Contact us if
you would like additional summaries.
F IG 2 . N o . o f p a tie n ts b y site o f p rim a ry
50
45
40
N o. of pa tie nts
35
30
25
20
15
10
5
0
B re a s t Lung P ro s ta te
S ite o f p rim a ry
Most patients entered into the trial are those who have prostate cancer as their primary.
The reason why so few breast and lung patients have been entered is because they are
more likely to have been on bisphosphonates in the previous 6 months thus excluding
them from the study. A suggestion at a previous meeting about the trial was that this
timeline should be reduced to 3 months – at the launch meeting it was decided not to
change this criteria at present.
Newsletter 03
RIB Trial Participating Centres
All centres receive a trial set-up visit before any patients can be entered into the trial.
These visits are a good opportunity for participants and trials centre staff to meet each
other.
RIB Trial Participating
Centres
Mount Vernon Barts Scunthorpe
Hillingdon Ipswich Oldchurch
Royal Marsden - Sutton Royal Devon Portsmouth
Royal Marsden- Fulham Rd Devon District Clatterbridge
Sheffield Plymouth Hammersmith
Velindre Nottingham Walsgrave
Charing Cross Leicester Warwick
Ealing Churchill George Eliot
St Marys Stoke Mandeville Solihull
Southampton Swindon Alexandra
Christie Lincoln Royal Surrey
Leeds Pilgrim Ninewells, Dundee *
Addenbrookes Derby Maidstone and Tunbridge Wells *
Royal Sussex Burton Kent and Canterbury *
Eastbourne Hull Birmingham *
Worthing Scarborough
Newcastle * visits pending
NEW TRIAL - SC20 –Coming Soon!
SC20 is a Phase III International Randomised Trial of Single versus Multiple Fractions for
Re-Irradiation of Painful Bone Metastases coordinated by the National Cancer Institute of
Canada Clinical Trials Group (NCIC CTG). It is at the final stage of ethical approval and
LREC packs will be distributed soon to those centres that have expressed an interest in this
trial.
If you would like to request an LREC pack for SC20 or more information,
please contact us (see details below).
CONTACT DETAILS
RIB Trial Coordinator Cancer Research UK and Principal Investigator
Orla Cummins UCL Trials Centre Dr Peter Hoskin
020 7679 8036 Stephenson House Marie Curie Research
158-160 North Gower Street Wing, Mount Vernon
RIB Trial Data Manager London NW1 2ND Hospital,
Sandrine Stefanidis Rickmansworth Road
020 7679 8013 Phone: 020 7679 8000 Northwood Middlesex
Fax: 020 7679 8001 HA6 2RN
Senior Trials Coordinator
Kathryn Monson E-mail rib@ctc.ucl.ac.uk
020 7670 8035