NCT06107920RecruitingPhase 3
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)
Source: ClinicalTrials.gov · Last updated 10 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 232 (estimated)
- First submitted
- 25 Oct 2023
- Start date
- 7 May 2024
- Primary completion date
- Aug 2031
- Lead sponsor
- University Hospital, Rouen
- Diseases
- Colorectal cancer
- NCT number
- NCT06107920
- EU CT number
- 2024-516456-17-00
- EudraCT number
- 2021-002588-23
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 232
- From 7 May 2024 to the primary completion date, Aug 2031
- 35 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient having received radiation therapy prior to surgery
- Contraindication to study neoadjuvant chemotherapy treatments
Other illness
- Rectal cancer located within 10 cm of the anal verge by endoscopy or under the peritoneal reflection at surgery
- History or current evidence on physical examination of central nervous system disease or; Peripheral neuropathy ≥ grade 1
- 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
- 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.
Other
- Contraindication to colectomy and/or anesthesia
- Metastatic spread at baseline assessment (lung, liver, peritoneal)
- Uracilemia ≥ 150 ng/ml (suggestive of complete DPD deficiency)
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (35)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Universitaire Amiens Picardie Coordinator of this site? Confirm its status | Amiens Cedex 1 | France | Recruiting |
| Centre Hospitalier Simone Veil De Beauvais Coordinator of this site? Confirm its status | Beauvais | France | Recruiting |
| CHU Besançon Coordinator of this site? Confirm its status | Besançon | France | Recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Bobigny Cedex | France | Recruiting |
| Hôpital Ambroise-Paré Coordinator of this site? Confirm its status | Boulogne-Billancourt | France | Recruiting |
| Centre Hospitalier Régional et Universitaire de Brest Coordinator of this site? Confirm its status | Brest | France | Recruiting |
| Centre Hospitalier Universitaire De Caen Normandie Coordinator of this site? Confirm its status | Caen Cedex 9 | France | Recruiting |
| Centre Hospitalier Regional Universitaire De Tours Coordinator of this site? Confirm its status | Chambray Les Tours | France | Recruiting |
| Centre Hospitalier De Colmar Coordinator of this site? Confirm its status | Colmar Cedex | France | Recruiting |
| Centre Hospitalier Universitaire de Dijon Coordinator of this site? Confirm its status | Dijon | France | Recruiting |
| Union Mut Gestion Groupe Hosp Mutualiste De Grenoble Coordinator of this site? Confirm its status | Grenoble | France | Recruiting |
| Centre Hospitalier Universitaire Grenoble Alpes Coordinator of this site? Confirm its status | Grenoble Cedex 9 | France | Recruiting |
| Centre Hospitalier De Versailles Coordinator of this site? Confirm its status | Le Chesnay Cedex | France | Recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Le Kremlin-Bicetre | France | Recruiting |
| Hopital Huriez Coordinator of this site? Confirm its status | Lille Cedex | France | Recruiting |
| Centre Hospitalier Et Universitaire de Limoges Coordinator of this site? Confirm its status | Limoges | France | Recruiting |
| Centre Hospitalier Regional De Marseille Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Hopital Saint Louis Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Groupe Hospitalier Diaconesses Croix Saint-Simon Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hopitaux Universitaires Pitie Salpetriere Coordinator of this site? Confirm its status | Paris Cedex 13 | France | Recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Paris Cedex 15 | France | Recruiting |
| Centre Hospitalier De Pau Coordinator of this site? Confirm its status | Pau Cedex | France | Recruiting |
| Centre Hospitalier Universitaire De Bordeaux Coordinator of this site? Confirm its status | Pessac Cedex | France | Recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Pierre-Bénite | France | Recruiting |
| Centre Hospitalier Universitaire de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Recruiting |
| Centre Hospitalier Universitaire Reims Coordinator of this site? Confirm its status | Reims Cedex | France | Recruiting |
| Centre Hospitalier Universitaire Rouen Coordinator of this site? Confirm its status | Rouen | France | Recruiting |
| Centre Hospitalier Universitaire De La Reunion Coordinator of this site? Confirm its status | St Denis | France | Recruiting |
| Centre Hospitalier General De St Denis Coordinator of this site? Confirm its status | St Denis Cedex | France | Recruiting |
| Institut de Cancérologie Strasbourg Europe Coordinator of this site? Confirm its status | Strasbourg | France | Recruiting |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex 2 | France | Recruiting |
| Centre Hospitalier Universitaire De Toulouse Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Recruiting |
| CHRU De Nancy Coordinator of this site? Confirm its status | Vandoeuvre Les Nancy Cedex | France | Recruiting |
Related publications
- Neoadjuvant chemotherapy for obstructive colon cancer derived by a stoma: Study protocol of the FRENCH-01 randomized phase III trial (COnCERTO Trial).Dig Liver Dis · 2026 · PMID 41945039
- The "decompressing stoma - neoadjuvant Folfox chemotherapy - colectomy" strategy for non-metastatic obstructive colon cancer: A French retrospective multi-institutional case series.Clin Res Hepatol Gastroenterol · 2026 · PMID 41713642
This page is information, not medical advice. Discuss any trial with your doctor.