PRODIGE 34 - ADAGE: Randomised phase III study evaluating adjuvant chemotherapy after resection of stage III colon adenocarcinoma in patients aged 70 and older

Other illness

• Another progressive malignant tumour (cancer not stabilised since less than 2 years)
• Rectal cancer (localised at less than 10 cm from the anal margin by endoscopy or sub-peritoneal)
• Patient with severe liver insufficiency

Lab values

• PMNs < 2,000/mm3 for group 1 and PMNs < 1,500/mm3 for group 2, platelets < 100,000/mm3 or haemoglobin < 9 g/dL

Other

• Neuropathy for the patients from group 1
• Known total or partial dihydropyrimidine dehydrogenase (DPD) deficiency
• Any contra-indication to the medicinal products used in the study (refer to the updated versions of the SPCs of the products used, in Appendix 8)
• Impossibility to undergo the trial's medical follow-up for geographical, social, or psychological reasons

• Age ≥ 70
• Effective contraception for male patients throughout the treatment and at least 6 months after stopping the oxaliplatin treatment
• Informed consent(s) signed
• Patient deemed fit by the MCM to receive chemotherapy
• Lee’s score (Appendix 1) examined and faxed to the RMAC
• Stage III upper rectal or colon adenocarcinoma
• Resection R0 of the primary tumour
• Start of the adjuvant chemotherapy possible within 12 weeks after the surgery
• No prior chemotherapy for colon cancer
• Initial geriatric “patient” self-questionnaire completed and faxed to the RMAC (Appendix 2)
• Initial geriatric “team” questionnaire completed and faxed to the RMAC (Appendix 3)