Chemotherapy before surgery for obstructing colon cancer treated first with a diverting stoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 randomized trial enrolls adults with non-metastatic obstructive colon adenocarcinoma who have been treated initially with a diverting stoma. Participants receive neoadjuvant chemotherapy prior to elective colectomy, with postoperative chemotherapy given as indicated by surgical pathology. The study compares the proportion of patients who can complete the intended full treatment course, and also monitors surgical outcomes, safety, and tumor response. Imaging, pathology, and routine labs are used to guide treatment decisions and eligibility throughout the protocol.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• Chu Amiens
  Amiens, France Recruiting
• Chr Beauvais
  Beauvais, France Recruiting
• Chru Besancon
  Besançon, France Recruiting
• Aphp Avicenne
  Bobigny, France Recruiting
• Chu Caen
  Caen, France Recruiting
• Aphp Antoine Beclere
  Clamart, France Recruiting

Study contacts

• Study coordinator: Valérie Bridoux
• Email: valerie.bridoux@chu-rouen.fr
• Phone: 0232881347

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.