CAPECITABINE for Colon adenocarcinoma|Upper rectal adenocarcinoma

Inclusion criteria

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

Exclusion criteria

• {"criterion_text":"- Another progressive malignant tumour (cancer not stabilised since less than 2 years)"}
• {"criterion_text":"- Rectal cancer (localised at less than 10 cm from the anal margin by endoscopy or sub-peritoneal)"}
• {"criterion_text":"- PMNs < 2,000/mm3 for group 1 and PMNs < 1,500/mm3 for group 2, platelets < 100,000/mm3 or haemoglobin < 9 g/dL"}
• {"criterion_text":"- Neuropathy for the patients from group 1"}
• {"criterion_text":"- Known total or partial dihydropyrimidine dehydrogenase (DPD) deficiency"}
• {"criterion_text":"- Patient with severe liver insufficiency"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- Impossibility to undergo the trial's medical follow-up for geographical, social, or psychological reasons"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is relapse-free survival (RFS). It is defined as the time limit between the randomisation date and the date of the first recurrence (local or remote) or the date of death, regardless of the cause. All second cancers, colon or not, shall not be taken into account. The living patients without recurrence shall be censored at the date of their last assessment.","definition_or_measurement_approach":"It is defined as the time limit between the randomisation date and the date of the first recurrence (local or remote) or the date of death, regardless of the cause. All second cancers, colon or not, shall not be taken into account. The living patients without recurrence shall be censored at the date of their last assessment."}

Secondary endpoints

• {"endpoint_text":"- The dose intensity","definition_or_measurement_approach":""}
• {"endpoint_text":"- The overall tolerance to the treatments","definition_or_measurement_approach":""}
• {"endpoint_text":"- The time to recurrence","definition_or_measurement_approach":""}
• {"endpoint_text":"- Overall survival","definition_or_measurement_approach":""}
• {"endpoint_text":"- The time to decrease in autonomy","definition_or_measurement_approach":""}
• {"endpoint_text":"- The time to decrease in the quality of life","definition_or_measurement_approach":""}

Belgium

Earliest CTIS Part Ii Submission Date

06-11-2024

Latest Decision Or Authorization Date

17-01-2025

Processing Time Days

72

Number Of Sites

1

Number Of Participants

29

France

Earliest CTIS Part Ii Submission Date

06-11-2024

Latest Decision Or Authorization Date

29-01-2026

Processing Time Days

449

Number Of Participants

944

Primary sponsor

Full Name

Fondation Franc.Cancerologie Digestive

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"France","full_name":"CRB EPIGENETEC","duties_or_roles":"sample archiving","organisation_type":"Health care"}