NL-OMON20322
Completed
Not Applicable
A Multicenter Phase III Randomised Trial comparing Total Mesorectal Excision with Pre-operative Radiotherapy with or without Post-operative Oral Capecitabine in the Treatment of Operable Primary Rectal Cancer.
Dutch Colorectal Cancer Group0 sites840 target enrollmentTBD
ConditionsRectal cancer, tumor
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rectal cancer, tumor
- Sponsor
- Dutch Colorectal Cancer Group
- Enrollment
- 840
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
/A
Investigators
Eligibility Criteria
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;
Outcomes
Primary Outcomes
Not specified
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