6th April 2011 – Trial Design Updates
As documented in section 9 of the STAMPEDE protocol the trial is
using a multi-arm,
multi-stage (MAMS) method to assess the 5 research
arms against the common control arm. We recently came to
the end of Activity Stage II when we had sufficient data for
the IDMC to assess the 6 trial arms in the 2nd planned intermediate
activity analysis.
Following this, the STAMPEDE Trial Steering Committee (TSC)
met on the 6th of April and decided that recruitment
should be stopped to the celecoxib-containing trial arms, D
and F due to a lack of sufficient benefit. We will be
contacting all centres in the next few days with more detailed
recommendations concerning the patients already on treatment. It is
very important that follow-up continues for all of these patients
as per the protocol.
Recruitment to arms A, B, C and E continues unchanged as these
passed the pre-specified intermediate hurdle for activity. You can
continue to recruit patients without waiting for further
information from us.
The possibility of stopping recruitment
to arms has always been an integral part of the trial’s design
and is built into the approved protocol; hence this does not
constitute a substantial amendment and can be initiated straight
away. This has been confirmed in writing with the MHRA and the main
Ethics Committee, please
click here to access the confirmation document.
Please
click here to access a copy of the email that was sent out to
all centres on April 6th.
If you have any questions about this change
please contact a member of the trial team on stampede@ctu.mrc.ac.uk
We are now in activity stage 3 and will continue to recruit
patients to arms A, B, C and E. The STAMPEDE trial team here at the
CTU have been preparing for this possibility over the last few
months and will be working hard over the coming days and weeks to
implement this change as smoothly as possible. The results of this
analysis represent a significant milestone in this important trial
and the STAMPEDE team would like to thank everyone who has helped
us reach this point.
30th March 2011
As documented in section 9 of the STAMPEDE protocol the trial is
using multi-arm,
multi-stage (MAMS) methods to assess the 5 research
arms against the common control arm. We are currently in
Activity Stage II and now have sufficient data to assess the
current trial arms in an intermediate activity analysis.
The Independent Data Monitoring Committee (IDMC) will meet at
the end of March to review the data and make a recommendation to
the Trial Steering Committee (TSC), the trial’s executive body. The
recommendation will be on whether recruitment (and treatment)
should continue to each of the trial arms. The TSC will then decide
whether recruitment to any of the arms of the trial should be
discontinued at this point.
If the TSC do recommend that changes are made then
members of staff at the MRC CTU will be in contact with all centres
on the 7th and 8th of April to communicate the decision and inform
you of any changes that may need to be made locally. This is a very
exciting time for STAMPEDE and we will keep you updated every step
of the way!
For more information please click
here to view the letter that was sent out to the Principal
Investigators at all sites and
click here to access the letter from the MHRA.