EUCTR2006-006532-21-DE
Active, not recruiting
Phase 1
Preoperative chemoradiotherapy and postoperative chemotherapy with capecitabine and oxaliplatin vs. capecitabine alone in locally advanced rectal cancer (PETACC-6) - PETACC-6
Conditionslocally advanced rectal cancerMedDRA version: 17.0Level: PTClassification code 10038050Term: Rectal cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: PTClassification code 10038049Term: Rectal cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- locally advanced rectal cancer
- Sponsor
- EORTC
- Enrollment
- 1094
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female patients with histologically proven adenocarcinoma of the rectum (tumour \= 12
- •cm from the anal verge as assessed by rigid proctoscopy).
- •¨ Clinical tumour stage T3/4 or any node\-positive disease (clinical stage according the TNM
- •classification system (Appendix J), positive nodes as diagnosed on endorectal ultrasound and/or
- •MRI). Tumour is staged by preferably a high resolution MRI. If MRI is not available,
- •locoregional staging must be performed by computed tomography plus endorectal ultrasound.
- •¨ No evidence of metastatic disease (as evidenced by negative CT\-scan of the chest and
- •¨ The disease must be considered either resectable at the time of entry or expected to become
- •resectable after preoperative chemoradiation.
- •¨ Age \= 18 years.
Exclusion Criteria
- •\-severe renal impairment (creatinine clearance below 30 ml/min)
- •\-pregnancy and lactation
- •\-hypersensitivity to capecitabine or 5\-FU or to any of the excipients
- •\-patients with history of severe and unexpected reactions to fluoro pyrimidine therapy
- •\-patients with known dihydropyrimidine dehydrogenase (DPD) deficiency
- •\-patients with severe leucopenia, neutropenia and thrombocytopenia
- •\-severe hepatic impairment
- •\-concomittant use of sorivudine or its chemically related analogues such as brivudine
- •\-patients with known allergy against oxaliplatin or other platinum compounds
- •\-patients with impaired bone marrow function
Outcomes
Primary Outcomes
Not specified
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