Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neoadjuvant chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Arm I (Adjuvant chemotherapy) / Control arm
- description
- Diverting stoma - colectomy - +/- adjuvant chemotherapy The colectomy (open or laparoscopic) should be performed within 1 to 20 days after the randomization and with respect of the oncological quality criteria of resection. After completion of surgery, adjuvant chemotherapy will be discussed as follow: * Low-risk stage II: No adjuvant treatment * High-risk MSS stage II (vascular emboli, lymphatic or perinervous invasion, poor differentiation, \<12 harvested lymph nodes, perforation): Investigator's discretion * pT1-T3N1: CAPOX (3 months) or FOLFOX (6 months) * pT4 and/or N2: FOLFOX (6 months)
- type
- EXPERIMENTAL
- label
- Arm II (Neoadjuvant Chemotherapy) / Experimental arm
- description
- Patients receive systemic CAPOX or FOLFOX chemotherapy (3 months) within 21 days after the randomization. After completion of neoadjuvant chemotherapy and within 3 to 5 weeks, the colectomy (open or laparoscopic) will be performed with respect of the oncological quality criteria. Adjuvant chemotherapy will be discussed as follow: * Low-risk stage II: No adjuvant treatment * High-risk MSS stage II (vascular emboli, perinervous or lymphatic invasion, poor differentiation, \<12 harvested lymph nodes, perforation): Investigator's discretion * Stage III: CAPOX or FOLFOX (3 months)
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDBridoux V, Fernandez B, Sabbagh C, Hitier M, Kepenekian V, Amroun KL, Bouquot M, Lakkis Z, Ouaissi M, Darrius R, Dubreuil O, Duchalais E, Moreno-Lopez N, Trilling B, Zemour J, Beyer L, Alves A, Mauvais F, Noullet S, Romero R, Tresallet C, Badic B, Benoist S, Eveno C, Jeune F, Germain A, Duffas JP, Lefevre JH, Maggiori L, Manceau G, Marchese U, Mege D, Flesch H, Romain B, Tourreau Y, Zerbib P, Vychnevskaia K, Karoui M. 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 Jun;58(6):759-764. doi: 10.1016/j.dld.2026.03.006. Epub 2026 Apr 6. PMID 41945039
- DERIVEDBajul M, Meillat H, Fernandez B, Christou N, Gallois C, Cazelles A, Labiad C, Taieb J, Manceau G, Karoui M. 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 Apr;50(4):102787. doi: 10.1016/j.clinre.2026.102787. Epub 2026 Feb 17. PMID 41713642