Oxaliplatin for Colon cancer (stage II)

Inclusion criteria

• {"criterion_text":"- Signed written informed consent obtained prior to any study specific procedures"}
• {"criterion_text":"- No prior chemotherapy for colo-rectal cancer"}
• {"criterion_text":"- No prior abdominal or pelvic irradiation for colo-rectal cancer"}
• {"criterion_text":"- Life expectancy of ≥ 5 years"}
• {"criterion_text":"- Adequate haematological function: with neutrophils ≥ 1,500 /mm3, platelet count ≥ 100,000/mm3, hemoglobin ≥ 9 g/dL (5,6 mmol/l)"}
• {"criterion_text":"- Total bilirubin ≤ 1.5 x ULN (upper limit of normal)"}
• {"criterion_text":"- ASAT and ALAT ≤ 2.5 x ULN"}
• {"criterion_text":"- Alkaline phosphatase ≤ 2.5 x ULN"}
• {"criterion_text":"- Serum creatinine ≤ 120 μmol/L or creatinine clearance ≥50 ml/min according MDRD (Modification of Diet in Renal Disease)"}
• {"criterion_text":"- Carcinoembryogenic antigen (CEA) ≤ 1.5 x ULN after surgery (during screening period)"}
• {"criterion_text":"- Negative pregnancy test for registration (for women of childbearing age)"}
• {"criterion_text":"- Age ≥ 18 years and ≤ 80 years (provided the score of the G8 geriatric questionnaire is >14 for patients 70 years or older)"}
• {"criterion_text":"- Patient affiliated to a social security system"}
• {"criterion_text":"- Histologically confirmed stage II colon and high rectum adenocarcinoma excluding low and medium rectal cancers (tumor location ≥ 12 cm from the anal verge by endoscopy and/or above the peritoneal reflection at surgery are still eligible), without gross or microscopic evidence of residual disease after surgery with curative intent. Pathology report must be faxed to CRGA just after patient’s randomization."}
• {"criterion_text":"- At least 12 lymph nodes analyzed"}
• {"criterion_text":"- Patient with MSI + tumors can also be included"}
• {"criterion_text":"- All patients must have been discussed in multidisciplinary meetings with a decision of not performing adjuvant chemotherapy"}
• {"criterion_text":"- No metastatic disease on CT-Scan and/or liver MRI done within 3 months before randomization."}
• {"criterion_text":"- Randomization planned up to 11 weeks maximun after curative R0 resection"}
• {"criterion_text":"- WHO performance Status < 2"}

Exclusion criteria

• {"criterion_text":"- T4b tumors"}
• {"criterion_text":"- Lack of effective contraception in patients (men and/or women) of childbearing age, pregnant or breastfeeding women. Men engaging in sexual activity with women of childbearing potential, and women of childbearing potential should agree to use a method of contraception during treatment of the trial and at least 6 months after discontinuation of said treatment."}
• {"criterion_text":"- Stage I tumors (T1 or T2N0)"}
• {"criterion_text":"- Peripheral neuropathy > grade 1"}
• {"criterion_text":"- Comorbidity influencing the 5-year patients’ survival including clinically relevant cardiovascular disease"}
• {"criterion_text":"- Ischemic myocardial infarction in the last year and/or unstable ischemic cardiopathy"}
• {"criterion_text":"- Participation to another interventional study for postoperative therapy"}
• {"criterion_text":"- study for postoperative therapy - Partial"}
• {"criterion_text":"- Legal incapacity or physical, psychological social or geographical status interfering with the patient's ability to sign the informed consent or to finish the study"}
• {"criterion_text":"- Medical history of other concomitant or previous malignant disease, except adequately treated in situ carcinoma of the uterine cervix, basal or squamous cell carcinoma of the skin, or cancer in complete remission for ≥ 5 years,"}

Primary endpoints

• {"endpoint_text":"- improve 3-year DFS from 25% to 42.5% by the use of adjuvant chemotherapy","definition_or_measurement_approach":"Disease Free Survival (DFS) at 3 years (3-year DFS); target improvement from 25% to 42.5% with adjuvant chemotherapy."}

Secondary endpoints

• {"endpoint_text":"- Time to Recurrence (TTR)","definition_or_measurement_approach":"Time to recurrence measured from randomization to documented recurrence."}
• {"endpoint_text":"- Overall Survival (OS)","definition_or_measurement_approach":"Overall survival measured from randomization to death from any cause."}
• {"endpoint_text":"- compare DFS and OS in ctDNA positive versus ctDNA negative patients,","definition_or_measurement_approach":"Comparison of DFS and OS between ctDNA-positive and ctDNA-negative patients (no adjuvant treatment subgroup comparisons described)."}
• {"endpoint_text":"- toxicities using NCI-CTC v4 classification","definition_or_measurement_approach":"Toxicities graded using NCI-CTC version 4.0."}
• {"endpoint_text":"- success rate of prognostication of stage II colo-rectal cancer","definition_or_measurement_approach":"Rate of successful prognostication of stage II colorectal cancer (methodology not detailed in provided data)."}

France

Earliest CTIS Part Ii Submission Date

18-07-2024

Latest Decision Or Authorization Date

14-04-2026

Processing Time Days

635

Number Of Participants

142

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Dijon

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"United States","full_name":"Natera Inc.","duties_or_roles":"code: 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"France","full_name":"Fondation Franc.Cancerologie Digestive","duties_or_roles":"codes: 1,10,12,2,5,6,8","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"France","full_name":"CRB EPIGENETEC","duties_or_roles":"sample archiving; code: 4","organisation_type":"Health care (Research Biobank/CRB)"}