Headline News: Our Data Monitoring Committee applaud SEND recruitment. They find statistical significance in interim results and recommend trial closure to new patients, rapid publication and maintain follow up of all patients for 5 years.
The SEND trial is looking at two commonly used surgical techniques for the treatment of early mouth cancer. After an early analysis of the results, our Data Monitoring Committee have found that there is enough evidence available to determine the best course of treatment for patients and so our flagship clinical trial will no longer be recruiting patients. Over the coming months we will be collecting and analysing the final data. We will be publishing the results in the near future.
A message from the Chief Investigator, Prof Iain Hutchison.
This is a brief letter to bring you up to speed about the state of SEND.
Firstly, I would like to thank you for the immense effort you have given to make this prospective randomised trial (PRT) succeed.
You may remember that SEND is half funded by Cancer Research UK (CRUK) and half funded by Saving Faces–The Facial Surgery Research Foundation (Saving Faces). The CRUK grant ceases this year but Saving Faces and the National Facial and Oral Research Centre (NFORC) will continue to fund and support the follow-up of all patients.
A total of 599 patients are being followed up in SEND and the 2 sub-trials including:
- 255 SEND patients – who have been entered into the randomised study.
- 141 NON SEND patients who declined randomisation but agreed to complete questionnaires and donate blood and tissue samples in the sub-trial.
- 203 NR patients who were not approached for randomisation usually because the clinician felt that reconstruction was necessary, or the patients were not fit for a long operation.
- Additionally, we have ethical approval to survey both SEND and NON SEND patients and study their attitudes towards participation in randomised and non-randomised surgical trials. Our results will help to inform the design of future surgical PRTs.
I have been aware of the similar study from TATA Memorial Hospital in Mumbai led by my friend and colleague Prof Anil D’Cruz for several years.
Anil and I first discussed collaboration between our two studies about five years ago. Their study started two years before ours and recruited at a slightly faster rate.
In the UK we quickly gained approval to share our data with TATA Memorial. Unfortunately, despite many conversations and emails, Anil was unable to persuade his institutional ethics board or the Indian Council of Medical Research (ICMR) to allow him to merge TATA’s data with ours. We both agreed that this was a shame because it would have resulted in earlier trial closure and increased the international relevance of the results.
SEND Data Monitoring Committee (DMC)
Our DMC attempted to contact TATA with a view to merging the two datasets in early 2015. Unfortunately this did not prove possible because of the lack of support from the ICMR.
Our DMC was aware of the imminent presentation of the TATA data at ASCO in the USA last month so arranged to discuss our data in light of the TATA report on July 14th 2015.
They have now contacted me with their findings. Firstly, they complimented us on trial recruitment. An interim analysis of our data revealed significant results that in combination with the TATA results justify stopping recruitment. However they wish us to continue to assess survival and disease free survival for patients who are currently under study.
Our trial statistician, Allan Hackshaw, is analysing the data with a view to submission for publication in the autumn.
I would like to thank all the clinicians, patients and support staff who have made this trial a sucess. I sincerely hope that this will be the first of many future trials that we can run together.
Very best wishes