New CRFs released for protocol version 9.0
All STAMPEDE CRFs have
been updated and are available for download here.
Detail form (Form 9) needs to be completed for all
patients recruited from 22/01/2013. For patients who receive RT, it
should be completed when the patient's course of primary RT is
completed. For patients who do not receive primary RT, it should be
completed 10 months after randomisation to confirm that RT was not
given. This form replaces the previous Radiotherapy form. Further
guidance on completion is available on the CRF.
Acute Toxicity form (Form 9a) is to be completed for all
patients who receive primary RT. For patients on Arm H of the trial
(research RT arm) it should be completed 10 weeks after the start
of RT. For all other patients it should be completed 18 weeks after
the start of RT.
Late radiotherapy toxicity
data is now collected for all patients via the
Follow Up form (Form 7). Please see page 4 of Form
7 for more information.
All new CRFs should
be used with immediate effect for all patients.
The CRF completion
guidelines can be found here.