OXALIPLATIN for Colon cancer|Obstructive colon cancer

Inclusion criteria

• {"criterion_text":"- 1.\tAge ≥ 18 years"}
• {"criterion_text":"- 10.\tNo history of colorectal cancer"}
• {"criterion_text":"- 11.\tNo serious medical co-morbidity (uncontrolled inflammatory bowel disease, uncontrolled angina, recent [within the past 6 months] myocardial infarction, or another serious medical condition) judged to compromise ability to tolerate chemotherapy and/or surgery"}
• {"criterion_text":"- 12.\twomen participating in the study, contraception is required during chemotherapy treatment and for 15 months after cessation of chemotherapy treatment a)\tFor Women of childbearing potential an effective contraception is required and a negative blood pregnancy test by beta-HCG at inclusion and monthly pregnancy tests throughout the study until the end of systemic treatment exposure b)\tFor women surgically sterile the absence of ovaries and/or uterus is confirmed. c)\tFor postmenauposal women a confirmation diagnostic (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit) is required"}
• {"criterion_text":"- 13.\tFor men participating in the study, contraception is required during the trial and for 12 months after stopping chemotherapy treatment"}
• {"criterion_text":"- 14.\tPatient able to comply with the study protocol, in the investigator’s judgment"}
• {"criterion_text":"- 15.\tPatient affiliated with, or beneficiary of a social security (health insurance) category"}
• {"criterion_text":"- 16.\tPerson informed and having signed his consent"}
• {"criterion_text":"- 2.\tECOG performance status 0 or 1"}
• {"criterion_text":"- 3.\tPatients with obstructive colon cancer treated by defunctioning stoma"}
• {"criterion_text":"- 4.\tPathologically confirmed adenocarcinoma (≥10 cm from the anal verge) MSS/pMMR (microsatellite stable primary tumor) status"}
• {"criterion_text":"- 5.\tPatient requiring colectomy"}
• {"criterion_text":"- 6.\tLaboratory data including : White blood cell count ≥ 3.109 /L with Neutrophils ≥ 1,5.109 / L, Platelet count ≥ 100.109 / L, Hemoglobin ≥ 9 g/dL (5,6 mmol/L), Total bilirubin ≤ 1,5 x ULN (upper limit of normal), ASAT and ALAT ≤ 2,5 x ULN, Alkaline phosphatase ≤ 1,5 x ULN, Serum creatinine ≤ 1,5 x ULN (performed 10-15 days prior to randomization)"}
• {"criterion_text":"- 7.\tNon metastatic colon cancer on thoracic-abdomino-pelvis CT scan"}
• {"criterion_text":"- 8.\tno suspicion of 2nd colon cancer"}
• {"criterion_text":"- 9.\tNo prior chemotherapy or abdominal or pelvic irradiation"}

Exclusion criteria

• {"criterion_text":"- 1.\tContraindication to colectomy and/or anesthesia"}
• {"criterion_text":"- 2.\tRectal cancer located within 10 cm of the anal verge by endoscopy or under the peritoneal reflection at surgery or having received radiation therapy prior to surgery"}
• {"criterion_text":"- 3.\tPatient having received radiation therapy prior to surgery"}
• {"criterion_text":"- 4.\tMetastatic spread at baseline assessment (lung, liver, peritoneal)"}
• {"criterion_text":"- 5.\tHistory or current evidence on physical examination of central nervous system disease or; Peripheral neuropathy ≥ grade 1 common toxicity criteria for adverse events NCI-CTCAE (version 5.0)"}
• {"criterion_text":"- 6.\tContraindication to study chemotherapy treatments"}
• {"criterion_text":"- 7.\tPresence of inflammatory bowel disease HNPCC syndrome or polyposis"}
• {"criterion_text":"- 8.\tClinically relevant coronary artery disease or history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia"}
• {"criterion_text":"- 9.\tUracilemia ≥ 150 ng/ml (suggestive of complete DPD deficiency)"}
• {"criterion_text":"- 10.\tMedical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent"}
• {"criterion_text":"- 11.\tAny significant disease, which, in the investigator’s opinion, would exclude the patient from the study."}
• {"criterion_text":"- 12.\tPatient is a pregnant (positive blood pregnancy test) or breastfeeding (lactating) woman or intending to become pregnant during the study and for at least 15 months after the chemotherapy treatment termination"}
• {"criterion_text":"- 13.\tPerson deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)"}
• {"criterion_text":"- 14.\tSimultaneous participation in another interventional research"}

Primary endpoints

• {"endpoint_text":"- the success of a full curative therapeutic","definition_or_measurement_approach":"Measured as the rate of complete curative therapeutic sequence (compare rate of complete curative therapeutic sequence between neoadjuvant CAPOX/FOLFOX and adjuvant strategy) as described in the main objective."}

Secondary endpoints

• {"endpoint_text":"-\tTolerability (grade 3, 4 and 5 toxicity) and compliance (number of cycles) of neoadjuvant chemotherapy","definition_or_measurement_approach":""}
• {"endpoint_text":"-\tTolerability (grade 3, 4 and 5 toxicity) of adjuvant chemotherapy","definition_or_measurement_approach":""}
• {"endpoint_text":"-\tPrimary tumour resection (rate, quality and completeness of the surgical excision)","definition_or_measurement_approach":""}
• {"endpoint_text":"-\tPostoperative morbidity according to Dindo classification","definition_or_measurement_approach":""}
• {"endpoint_text":"-\tDisease-free survival at 3 years","definition_or_measurement_approach":""}
• {"endpoint_text":"-\tOverall survival at 3 years","definition_or_measurement_approach":""}
• {"endpoint_text":"-\tSurvival without stoma at 3 years","definition_or_measurement_approach":""}
• {"endpoint_text":"-\tQuality of life at week5 (FOLFOX)/week7 (CAPOX), week9 (FOLFOX) and every 6 months a year","definition_or_measurement_approach":""}

France

Earliest CTIS Part Ii Submission Date

20-08-2024

Latest Decision Or Authorization Date

17-07-2025

Processing Time Days

331

Number Of Sites

39

Number Of Participants

232

Primary sponsor

Full Name

Centre Hospitalier Universitaire Rouen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France