Operable rectal cancer: Survey of current practice and proposed phase III trial

Posted 17 July 2014 in

Dear colorectal MDT member

Following successful completion of recruitment to the UK phase II COPERNICUS feasibility trial in May 2014, which examined neoadjuvant oxaliplatin/fluorouracil chemotherapy prior to short course preoperative radiotherapy then surgery, we are developing a proposal for a follow-on phase III trial called CREATE (Chemotherapy, Radiotherapy or Each Then Excision for Operable Rectal Cancer at High Risk of Systemic Recurrence), to be submitted to CRUK in the second half of 2014.

CREATE is concerned with a similar group of patients to those that entered COPERNICUS i.e. rectal adenocarcinoma that is operable on pre-treatment pelvic MRI (because it does not threaten or involve the surgical CRM i.e. at least 1mm between disease and the CRM), with no detectable distant metastases but which is at high risk of subsequent metastatic relapse following surgical resection. In such patients distant metastatic relapse rather than pelvic recurrence is now overwhelmingly the main cause of death. CREATE examines the effectiveness of neoadjuvant preoperative chemotherapy in being able to reduce subsequent metastatic relapse and therefore improve survival.

We are widely disseminating this survey to firstly assess variability in current clinical practice in this group of patients and secondly to gauge support for CREATE. Although it is possible that several members of each MDT may receive this invitation, we would like the members of your MDT as a whole to consider the questions in the survey, obtaining a consensus view of all key members including surgeons and oncologists and therefore for one survey only to be completed by each MDT. We would be very grateful if we could receive your replies by the end of August 2014 in order to assimilate and consider the responses ahead of the proposal submission.

Please refer to the pdf ‘CREATE Survey’ which describes the trial rationale, has details of the clinical cases for consideration and the web address of the SurveyMonkey website where the survey answers should be entered electronically.

Thank you in anticipation for your help.

Simon Gollins, Consultant Clinical Oncologist, North Wales Cancer Treatment Centre

on behalf of the UK NCRI Colorectal CSG Anorectal Subgroup

Tel: 01745 448774 ext 7963

Email Simon Gollins


Chris Hurt, Senior Statistician, Wales Cancer Trials Unit, Cardiff

Tel: 02920 687471

Email Chris Hurt