Neoadjuvant Chemotherapy for Obstructive Colon cancER First Treated by cOlostomy
COnCERTO
1 other identifier
interventional
232
1 country
28
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2024
Longer than P75 for phase_3
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2023
CompletedFirst Posted
Study publicly available on registry
October 30, 2023
CompletedStudy Start
First participant enrolled
May 7, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2031
February 10, 2026
February 1, 2026
7.2 years
October 25, 2023
February 5, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
the success of a full curative therapeutic
The treatment is complete if all the chemotherapy treatments (adjuvant for arm I / neoadjuvant and adjuvant for arm II) is done.
36 months
Secondary Outcomes (8)
Neoadjuvant chemotherapy Adverse events
36 months
adjuvant chemotherapy adverse events
36 months
Number of cycles administered of neoadjuvant chemotherapy
36 months
Rate of primary tumour resection
36 months
Quality and completeness of the surgical excision
36 months
- +3 more secondary outcomes
Study Arms (2)
Arm I (Adjuvant chemotherapy) / Control arm
NO INTERVENTIONDiverting 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)
Arm II (Neoadjuvant Chemotherapy) / Experimental arm
EXPERIMENTALPatients 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)
Interventions
Diverting stoma- neoadjuvant chemotherapy - colectomy - +/- adjuvant chemotherapy
Eligibility Criteria
You may qualify if:
- 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 surgically sterile (absence of ovaries and/or uterus)
- 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
- +1 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Chu Amiens
Amiens, 80054, France
Chr Beauvais
Beauvais, 60021, France
Chru Besancon
Besançon, 25030, France
Aphp Avicenne
Bobigny, 93000, France
CHU CAEN
Caen, 14000, France
Aphp Antoine Beclere
Clamart, 92140, France
Chu Colmar
Colmar, 68024, France
Chu Dijon
Dijon, 21079, France
Chu Grenoble
Grenoble, 38043, France
Aphp Kremlin Bicetre
Le Kremlin-Bicêtre, 94275, France
Chru Lille
Lille, 59037, France
Chru Lille
Lille, 59037, France
Chu Limoges
Limoges, 87042, France
Aphm La Timone
Marseille, 13005, France
Aphm Hopital Nord
Marseille, 13015, France
Chru Nancy
Nancy, 54511, France
Chu Nantes
Nantes, 44093, France
Aphp Saint Antoine
Paris, 75012, France
Aphp Cochin
Paris, 75014, France
Aphp Georges Pompidou
Paris, 75015, France
Gh Diaconesses Croix St Simon
Paris, 75960, France
CHU LYON
Pierre-Bénite, 69495, France
Ch Poissy
Poissy, 78303, France
Chu Rouen
Rouen, 76031, France
Ch St Denis
Saint-Denis, 93200, France
Chu Strasbourg
Strasbourg, 67200, France
Chu Tours
Tours, 37170, France
Ch Versailles
Versailles, 78150, France
Related Publications (1)
Bajul 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 Feb 17;50(4):102787. doi: 10.1016/j.clinre.2026.102787. Online ahead of print.
PMID: 41713642DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2023
First Posted
October 30, 2023
Study Start
May 7, 2024
Primary Completion (Estimated)
August 1, 2031
Study Completion (Estimated)
August 1, 2031
Last Updated
February 10, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share