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Clinical Trials/NL-OMON20322
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

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

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Dutch Colorectal Cancer Group

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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