IRinotecan and Oxaliplatin for Colon Cancer in Adjuvant Setting

• Status: Recruiting
• Trial end date: 2027-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The trial is a phase III, multicenter, open-labeled randomized trial comparing the association 5-fluorouracil (5-FU), folinic acid, irinotecan and oxaliplatin (mFOLFIRINOX) versus oxaliplatin, folinic acid, 5-FU (mFOLFOX 6) chemotherapy protocols in patients with high-risk stage III colon cancer in the adjuvant setting.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNICANCER
• Collaborators: Canadian Cancer Trials Group; GONO GROUP
• Treatments: Camptothecin; Fluorouracil; Irinotecan; Leucovorin; Oxaliplatin

Criteria

DIAGNOSIS AND INCLUSION CRITERIA:

1. Patient ≥18 years and < 75 years

2. Patient ≥18 years and <71 years must have an ECOG ≤1 - Patients ≥71 years and < 75 years must have an ECOG = 0

3. Pathologically confirmed high-risk stage III colon adenocarcinoma, restricted to pT4N1 or pT1-4N2 tumor.

4. Curative R0 surgical resection.

5. Patients who have undergone surgery for colon cancer, defined as a tumor location >12 cm from the anal verge by endoscopy and/or above the peritoneal reflection at surgery (high rectum), without gross or microscopic evidence of residual disease after surgery with curative intent

6. Start of study drug treatment has to be performed less than 56 days after surgery.

7. No prior chemotherapy.

8. No prior abdominal or pelvic irradiation.

9. Patient with adequate organ function:

• Absolute neutrophil count (ANC) ≥ 2 x 109/L

• Haemoglobin ≥9 g/dL

• Platelets (PTL) ≥100 x 109/L

• AST/ALT ≤2.5 x ULN

• Alkaline phosphatase ≤2.5 x ULN

• Total Bilirubin ≤1.5 x ULN (Upper Limit of Normal)

• Creatinine clearance ≥50 mL/min (Cockcroft and Gault formula)

• Kalemia, magnesemia, calcemia ≥ 1 LLN (Lower Limit of Normal)

• Carcinoembryogenic antigen (CEA) ≤10ng/mL after surgery (during screening period)

10. Adequate contraception if applicable.

11. Patient able and willing to comply with study procedures as per protocol

12. Patient able to understand and willing to sign and date the written voluntary informed consent form at screening visit prior to any protocol-specific procedures

13. Public or private health insurance coverage

14. Life expectancy of > or = at 5 years

15. Uracilemia < 16 ng/ml (only for french centers)

Exclusion Criteria:

1. Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to study treatment start. Incompletely healed wounds or anticipation of the need for major surgical procedure during the course of the study

2. Metastatic disease

3. Presence of inflammatory bowel disease and/or ileus

4. Known hypersensitivity reaction to any of the components of study treatments.

5. Pregnancy (absence to be confirmed by β-hCG test) or breast-feeding period

6. Clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia (for men: QTc ≥450 msec, for women: QTc ≥470 msec)

7. Previous malignancy in the last 5 years except curative treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix

8. Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent

9. History or current evidence on physical examination of central nervous system disease or peripheral neuropathy ≥ grade 1 Common Toxicity Criteria for Adverse Events (CTCAE) v4.03.

10. Any significant disease which, in the investigator's opinion, would exclude the patient from the study.

11. Patient with a DPD deficiency or UGT1A1 homozygous 7/7; the test should be done for all patients before 5-FU administration, according to ANSM communication regarding recommendation about high risk of no testing DPD in patient before 5-FU administration; (Appendices 8 to 11).

12. Patients already included in another therapeutic trial involving an experimental drug