Status: Closed
Activation Date: 2002AUG23
Closing Date: 2005JUL29
Phase: III
Description: A Randomized Trial Comparing Pre-Operative Radiotherapy and Selective Post-Operative Chemoradiotherapy in Rectal Cancer.
Eligibility: Eligible patients have a histologically confirmed adenocarcinoma of the rectum (defined as lower edge of tumour within 15 cm of anal verge). The tumour must be considered potentially operable and patient must have no evidence of metastases.
Objective: The aim of this trial is to address the key question surrounding the use of radiotherapy in operable rectal cancer: Are local recurrence-free rates and quality of life optimized by giving all patients short course pre-operative radiotherapy, or is a preferable option to give post-operative chemoradiotherapy only to those at high risk of recurrence (i.e. with involved margins following surgery)?
Participation: Open to member centres
Lay Description: The standard treatment for cancer of the rectum is to remove it surgically and this remains the most important part of any treatment. However, for some patients we know that the addition of radiotherapy to the area of the tumour in the pelvis can improve the outcome of the surgical treatment. The purpose of this study is to establish whether this radiotherapy is helpful for all patients with the same kind of disease that you have and whether radiotherapy should be given before or after surgery. This research is being done because we do not know which method of giving radiotherapy is better.
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Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
GASTRO-INTESTINAL | CO16 | 59 | 2 | 0 | 2 |
(Core size is 0.6 mm)
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Fluid SamplesDisease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
GASTRO-INTESTINAL | CO16 | 59 | 0 | 0 |
Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
GASTRO-INTESTINAL | CO16 | 59 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |