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CR07 Summary |
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CR07
MRC trial summary can be found here http://www.ctu.mrc.ac.uk/studies/CR07.asp
Summary: A randomised trial to assess whether local recurrence-free rates and quality of life are optimised by giving all patients short course pre-operative radiotherapy, or to give post-operative chemo-radiotherapy only to those at high risk of recurrence.
Methods: Histologically confirmed adenocarcinoma of the rectum (defined as lower edge of tumour within 15cm of anal verge).
Operable
No mets
RCT
An update of the Dutch trial (TME vs pre-op RT + TME) presented at ASCO 2002 gave a LRR in the region of 2.5% for the pre-op RT arm.
Originallly the plan was to recruit 1800 patients, but to exclude a difference of >2.5%, with a LRR in the pre-op RT arm of 2.5% a total of 1350 patients are required (2-sided test, 5% significance level, 90% power).
Results: Presented at ASCO in June 2006.
A total of 1350 patients were randomised from 52 centres
The 3 year rates for LR (primary end point) were 4.7% and 11.1% for PRE and POST groups respectively
Disease free survival 79.5% and 74.9%
Overall survival 80.8% and 78.7%
The LR benefit in favour of PRE was consistent for tumours 0-5,5-10 and >10cm from the anal verge
Conclusions: Routine short course pre-operative radiotherapy results in a significant reduction in local recurrence and improved disease free survival at 3 years when compared with a highly selective post operative approach.
The main thrust of any discussion is the benefit of pre operative radiotherpy in terms of local recurrence. If you look at the history the Dutch trial halved the risk from 20-11%, but TME was not standard. CR07 in which TME was standard halved the risk of local recurrence from 11.1 -4.7%. Now the crux is that Bill Healds unit are produicing figures for TME in which the local recurrence rate is <4% BEFORE you start. Therefore giving pre op radiotherapy can half your risk to 2% but is it justified to give 100 people radiotherpay with alll the associated morbidity to benefit 2 out of 100?
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