Actively Recruiting
Neoadjuvant Chemotherapy for Obstructive Colon cancER First Treated by cOlostomy
Led by University Hospital, Rouen · Updated on 2026-02-10
232
Participants Needed
28
Research Sites
377 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Neoadjuvant Chemotherapy for Obstructive Colon cancER First Treated by cOlostomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- ECOG performance status 0 or 1
- Patients with obstructive colon cancer treated by defunctioning stoma
- Pathologically confirmed adenocarcinoma located at least 10 cm from the anal verge to left transverse colon with MSS/pMMR status
- Patient requiring colectomy
- Adequate laboratory values including white blood cell count, neutrophils, platelets, hemoglobin, bilirubin, liver enzymes, alkaline phosphatase, and serum creatinine within specified limits
- Non-metastatic colon cancer confirmed by 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 comorbidity that compromises ability to tolerate chemotherapy or surgery
- Women of childbearing potential must use effective contraception during and for 6 months after chemotherapy and have a negative pregnancy test at inclusion
- Women surgically sterile or postmenopausal with confirmed diagnostic status
- Men must use contraception during the trial and for 6 months after chemotherapy
- Patient able to comply with the study protocol as judged by investigator
- Patient affiliated with or beneficiary of social security
- Person informed and having signed consent
You will not qualify if you...
- Contraindication to colectomy and/or anesthesia
- Rectal cancer located within 10 cm of the anal verge or under the peritoneal reflection at surgery
- Prior radiation therapy before surgery
- Metastatic spread at baseline assessment
- History or current central nervous system disease or peripheral neuropathy grade 1 or higher
- Contraindication to neoadjuvant chemotherapy treatments
- Presence of inflammatory bowel disease, HNPCC syndrome or polyposis
- Clinically relevant coronary artery disease or recent myocardial infarction in 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 preventing completion of study or informed consent
- Any significant disease judged by investigator to exclude participation
- Pregnant or breastfeeding women or intending pregnancy during and for 6 months after treatment
- Person deprived of liberty by administrative or judicial decision or under judicial protection
- Simultaneous participation in another interventional research
AI-Screening
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Trial Site Locations
Total: 28 locations
1
Chu Amiens
Amiens, France, 80054
Actively Recruiting
2
Chr Beauvais
Beauvais, France, 60021
Actively Recruiting
3
Chru Besancon
Besançon, France, 25030
Actively Recruiting
4
Aphp Avicenne
Bobigny, France, 93000
Actively Recruiting
5
CHU CAEN
Caen, France, 14000
Actively Recruiting
6
Aphp Antoine Beclere
Clamart, France, 92140
Actively Recruiting
7
Chu Colmar
Colmar, France, 68024
Actively Recruiting
8
Chu Dijon
Dijon, France, 21079
Actively Recruiting
9
Chu Grenoble
Grenoble, France, 38043
Actively Recruiting
10
Aphp Kremlin Bicetre
Le Kremlin-Bicêtre, France, 94275
Actively Recruiting
11
Chru Lille
Lille, France, 59037
Actively Recruiting
12
Chru Lille
Lille, France, 59037
Actively Recruiting
13
Chu Limoges
Limoges, France, 87042
Actively Recruiting
14
Aphm La Timone
Marseille, France, 13005
Actively Recruiting
15
Aphm Hopital Nord
Marseille, France, 13015
Actively Recruiting
16
Chru Nancy
Nancy, France, 54511
Actively Recruiting
17
Chu Nantes
Nantes, France, 44093
Actively Recruiting
18
Aphp Saint Antoine
Paris, France, 75012
Actively Recruiting
19
Aphp Cochin
Paris, France, 75014
Actively Recruiting
20
Aphp Georges Pompidou
Paris, France, 75015
Actively Recruiting
21
Gh Diaconesses Croix St Simon
Paris, France, 75960
Actively Recruiting
22
CHU LYON
Pierre-Bénite, France, 69495
Actively Recruiting
23
Ch Poissy
Poissy, France, 78303
Actively Recruiting
24
Chu Rouen
Rouen, France, 76031
Actively Recruiting
25
Ch St Denis
Saint-Denis, France, 93200
Actively Recruiting
26
Chu Strasbourg
Strasbourg, France, 67200
Actively Recruiting
27
Chu Tours
Tours, France, 37170
Actively Recruiting
28
Ch Versailles
Versailles, France, 78150
Actively Recruiting
Research Team
V
Valérie Bridoux
CONTACT
J
Julie Rondeaux, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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