Randomised phase III trial evaluating adjuvant chemotherapy after the stage III colon adenocarcinoma resection for patient of 70 year old or more

Phase 1

• Conditions: Adjuvant treatment in stage III adenocarcinoma of the colon fully resected for patient of 70 years and over; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-002517-39-BE
• Lead Sponsor: Fédération Francophone de Cancérologie Digestive (FFCD)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-28
• Last Update Posted: 7 January 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

- Age = 70 years
- Patient considered enough fit to receive chemotherapy according to the multidiciplinary committee
- Lee score completed and faxed to the CRGA
- Stage III colonic adenocarcinoma or upper rectum
- R0 resection of the primary tumor
- Adjuvant chemotherapy can start within 12 weeks after surgery
- No prior chemotherapy for colon cancer
- Self-administered (patient) geriatric questionnaire completed and faxed to the CRGA
- Team geriatric questionnaire completed and faxed to the CRGA
- Effective contraception for male patients during treatment and for at least 6 months after discontinuation of oxaliplatin
- Signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

- Other progressive malignant tumor (cancer not stabilized for less than 2 years )
- Rectal cancer (located within 15 cm from the anal verge by endoscopy or below the peritoneal reflection )
- PNN < 2 000/mm3 for group 1 and PNN <1 500/mm3 for group 2, platelets <100000/mm3 or hemoglobin <9 g / dL
- Neuropathy for patients in group 1
- Known deficit of dihydropyrimidine dehydrogenase (DPD)
- Patients with severe hepatic impairment
- Any contra-indications for the drugs used in the study
- Geographical, sociological or psychological conditions that would not permit the patient to complete the medical study follow-up visits

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified