Status:
RECRUITING
Randomised Study Evaluating Adjuvant Chemotherapy After Resection of Stage III Colonic Adenocarcinoma in Patients of 70 and Over
Lead Sponsor:
Federation Francophone de Cancerologie Digestive
Conditions:
Colonic Adenocarcinoma
Eligibility:
All Genders
75+ years
Phase:
PHASE3
Brief Summary
Colorectal cancer occurs mainly in elderly patients. Recent estimation showed that in France more than 50% of the patients diagnosed with a colorectal cancer are 70 years old or more. Adjuvant chemoth...
Detailed Description
Colorectal cancer occurs mainly in elderly patients. Recent estimation showed that in France more than 50% of the patients diagnosed with a colorectal cancer are 70 years old or more. Adjuvant chemoth...
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 70 years
- Patient considered able to receive chemotherapy
- Lee score detailed faxed to CRGA
- Stage III colon adenocarcinoma
- R0 resection of the primary tumor
- Start of the potential adjuvant chemotherapy within 12 weeks after surgery
- No prior chemotherapy for colon cancer
- Geriatric Self-administered questionnaire completed faxed to CRGA
- Geriatric Questionnaire completed by the team faxed to CRGA
- Effective contraception for men patients throughout treatment and for at least 6 months after discontinuation of oxaliplatin
- Consent signed
Exclusion Criteria:
- Other progressive disease (cancer uncontrolled for less than 2 years)
- Rectal Cancer (located less than 15 cm from the anal verge endoscopy or sub-peritoneal)
- ANC <2000 / mm3 for group 1 and ANC <1500 / mm3 for group 2 and platelets <100,000 / mm3 or hemoglobin <9 g / dL
- Neuropathy for patients in group 1
- Known deficit of dihydropyrimidine dehydrogenase (DPD)
- Patients with severe hepatic insufficiency
- Any contrindication to the drugs used in the study
- Inability to submit to medical follow-up for geographical, social or psychological reasons.
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
774 Patients enrolled
Trial Details
Trial ID
NCT02355379
Start Date
January 1 2015
End Date
August 1 2025
Last Update
July 8 2024
Active Locations (140)
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1
CHU de Fort de France
Fort de France, Guadeloupe, France, 97261
2
CH d'Abbeville
Abbeville, France, 80142
3
CROMG
Agen, France
4
Centre hospitalier du Pays d'Aix
Aix-en-Provence, France, 13616