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

Neoadjuvant Chemotherapy for Obstructive Colon cancER First Treated by cOlostomy : A Randomized Phase III Trial - COnCERTO (French 01-18)

Phase 3 Interventional University Hospital, Rouen · NCT06107920

This trial will test whether giving chemotherapy before surgery helps adults with non-metastatic obstructive colon cancer who’ve had a diverting stoma to complete all planned cancer treatments.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment232 (estimated)
Ages18 Years and up
SexAll
SponsorUniversity Hospital, Rouen Academic / other
Drugs / interventionschemotherapy, radiation
Locations28 sites (Amiens and 27 other locations)
Trial IDNCT06107920 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with non-metastatic, microsatellite-stable colon adenocarcinoma causing obstruction who have received a diverting stoma, have ECOG 0–1, and meet standard laboratory criteria are ideal candidates.

Not a fit: Patients with metastatic disease, poor performance status, significant organ dysfunction, prior relevant chemo/radiation, or MSI-high tumors are unlikely to benefit from this specific neoadjuvant approach.

Why it matters

Potential benefit: If successful, this approach could increase the number of patients who complete both pre- and post-operative chemotherapy and potentially improve long-term cancer outcomes.

How similar studies have performed: Prior trials of neoadjuvant chemotherapy in locally advanced colon cancer (for example FOxTROT) have shown tumor downstaging and feasibility, but dedicated evidence for obstructive cancers managed with initial stoma is limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Amiens and 27 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Colon Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.