Neoadjuvant Chemotherapy for Obstructive Colon cancER First Treated by cOlostomy
Neoadjuvant Chemotherapy for Obstructive Colon cancER First Treated by cOlostomy : A Randomized Phase III Trial - COnCERTO (French 01-18)
University Hospital, Rouen
232 participants
May 7, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria18
- 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
Exclusion Criteria13
- Contraindication to colectomy and/or anesthesia
- Rectal cancer located within 10 cm of the anal verge by endoscopy or under the peritoneal reflection at surgery
- Patient having received radiation therapy prior to surgery
- Metastatic spread at baseline assessment (lung, liver, peritoneal)
- History or current evidence on physical examination of central nervous system disease or; Peripheral neuropathy ≥ grade 1
- Contraindication to study neoadjuvant chemotherapy treatments
- Presence of inflammatory bowel disease, HNPCC syndrome or polyposis Clinically relevant coronary artery disease or history of myocardial infarction in the last 6 months, or high risk of uncontrolled arrhythmia
- Uracilemia ≥ 150 ng/ml (suggestive of complete DPD deficiency)
- Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent
- Any significant disease, which, in the investigator's opinion, would exclude the patient from the study.
- Patient is a pregnant (positive blood pregnancy test) or breastfeeding (lactating) woman or intending to become pregnant during the study and for at least 6 months after the treatment termination
- Person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)
- Simultaneous participation in another interventional research
Interventions
Diverting stoma- neoadjuvant chemotherapy - colectomy - +/- adjuvant chemotherapy
Locations(28)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06107920