Neoadjuvant Chemotherapy for Obstructive Colon cancER First Treated by cOlostomy : A Randomized Phase III Trial - COnCERTO (French 01-18)
The aim of this study is to determine whether chemotherapy prior to tumor removal (neoadjuvant chemotherapy), in patients undergoing treatment for colon cancer in occlusion (CCO), would improve the rate of patients able to benefit from optimal treatment, i.e. complete treatment (including all neoadjuvant and adjuvant chemotherapy cures). This new strategy, which would combine chemotherapy before surgery and possibly post-operatively (depending on tumor analysis), could improve the prognosis of occluded colon cancers by treating circulating micrometastases and/or inducing a reduction in tumor size, thereby increasing the rate of complete resection.
• Age ≥ 18 years
• ECOG performance status 0 or 1
• Patients with obstructive colon cancer treated by defunctioning stoma
• Pathologically confirmed adenocarcinoma (≥10 cm from the anal verge- left transverse colon) - MSS/pMMR (microsatellites stable primary tumor) status
• Patient requiring colectomy
• Laboratory 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).
• Non metastatic colon cancer (lung, liver, peritoneal) on thoracic-abdomino-pelvis CT scan
• Absence of synchronous colorectal cancer
• No prior chemotherapy or abdominal or pelvic irradiation
• No history of colorectal cancer
• No 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
• Women of childbearing potential with effective contraception will be required during chemotherapy treatment and for 6 months after cessation of chemotherapy treatment and a negative blood pregnancy test by beta-HCG at inclusion.
• Women surgically sterile (absence of ovaries and/or uterus)
• Postmenopausal women: confirmation diagnostic (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit)
• For men participating in the study, contraception is required during the trial and for 6 months after stopping chemotherapy treatment.
• Patient able to comply with the study protocol, in the investigator's judgment
• Patient affiliated with, or beneficiary of a social security (national health insurance) category
• Person informed and having signed his consent