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Intervention protocol 09

Concomitant chemotherapy and irradiation in patients with locally advanced rectal cancer followed by watchful waiting

Objectives The standard treatment of patients with locally advanced rectal cancer is long-course chemo¬radiation followed by operation. There is now evidence that operation can be omitted in patients with complete clinical remission of the tumour. The purpose of the nationwide study is therefore to analyse patient material treated with chemotherapy and radiation followed by careful observation only.
Study outline (intervention) The study will be running from Oct. 2008 and the aim is to recruit 100 patients in the first phase. The first endpoint is the fraction of patients needing operation the first year after end of treatment. If this fraction is less than 25%, further 200 patients will be included. Second endpoints are recurrence rate, survival, and toxicity of the treatment. The toxicity will be recorded according to Common Terminology Criteria for Adverse Events (CTCAE) (v3.0).
Expected impact Omitting operation in patients with rectal cancer has self-evident considerable impact, if the treatment can be performed with reasonable level of toxicity and acceptable recurrence rate.
Linkages with work packages WP 1, 2, 6. There will be a need for WP01, WP02 and WP06 to improve the target definition and obtain new information on tumour biology.