Simply Capecitabine in rectal cancer after irradiation plus TME.
Completed
- Conditions
- Rectal cancer, tumor
- Registration Number
- NL-OMON20322
- Lead Sponsor
- Dutch Colorectal Cancer Group
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 840
Inclusion Criteria
1. Rectal adenocarcinoma confirmed by histological examination of the biopsy specimen, located below the level of S1/S2 on a barium enema, CT scan or MRI scan, or either located within 15 cm of the anal verge, measured during withdrawal of the flexible scope;
2. Preoperative short term hypofractioned radiotherapy (5x5 Gy);
Exclusion Criteria
1. Evidence of macroscopic residual disease (R2);
2. T1 or T2 tumour with the presence of micrometastasis without the presence of macrometastasis;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To investigate in rectal cancer patients, in a randomised fashion, whether post-operative chemotherapy leads to a substantial improvement in overall survival, when standardised TME-surgery and pre-operative radiotherapy and pathology are applied.
- Secondary Outcome Measures
Name Time Method 1. To investigate in a randomised fashion whether post-operative chemotherapy leads to a substantial improvement in local and distant tumour control, when standardised TME-surgery, pre-operative radiotherapy and pathology are applied; <br /><br>2. Standardisation and quality control of TME-surgery and pathology.