Actively Recruiting
Study Evaluating the Tailored Management of Locally-advanced Rectal Carcinoma
Led by Institut du Cancer de Montpellier - Val d'Aurelle · Updated on 2026-02-05
1075
Participants Needed
30
Research Sites
244 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Locally advanced rectal carcinoma raise the issue of both the oncological control, local and general, and the therapeutic morbidity. Surgery alone can cure only one out of two patients, radiochemotherapy improves the local control but the metastatic risk remains about 30% with enhanced postoperative morbidity and poor functional results. The tumor response to preoperative treatment is the major prognostic factor which revealed the aggressiveness of the tumor. To this day, there are no biologic predictive markers for tumor response. The purpose of this trial is to tailor the management according to the early tumoral response after short and intensive induction chemotherapy. MRI volumetric tumor response will be used to distinguish between good responders and bad responders. "Very good" responders will be randomized to either immediate surgery or radiochemotherapy followed by surgery (Standard arm: Cap 50).
CONDITIONS
Official Title
Study Evaluating the Tailored Management of Locally-advanced Rectal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written consent to participate
- Receiving FOLFIRINOX chemotherapy
- Aged over 18 years
- WHO performance status of 1 or better
- Histologically confirmed adenocarcinoma of the rectum
- Tumor located 1 to 12 cm from the upper part of the levator ani muscle
- No clear metastatic disease on CT scan
- MRI showing locally advanced tumor with specific features (CRM < 2 mm, or T3c-d with extra mural venous invasion, or T4a-b excluding bone and sphincteric invasion)
- Suitable for radical pelvic surgery and systemic therapy with Capecitabine
- Adequate blood counts, liver, kidney, and electrolyte function within 7 days prior to treatment
- Negative pregnancy test for women of reproductive potential within 7 days prior to treatment
- Agreement to use effective contraception during study and for 6 months after
- No evidence of chronic or acute ischemic heart disease
- Willing and able to comply with treatment and follow-up
- Affiliated with French Social Security System
You will not qualify if you...
- Tumor not measurable or not assessed by MRI before inclusion
- Ultra-low rectal tumor requiring radiotherapy due to location
- Active cardiac disease including congestive heart failure (NYHA class 2 or higher), unstable angina, recent heart attack, or arrhythmias needing anti-arrhythmic therapy (except beta blockers or digoxin)
- Another cancer within 5 years distinct from colorectal cancer (except some treated cancers)
- Recent arterial or venous thrombotic or embolic events within 6 months
- History of pelvic radiotherapy
- Contraindications to chemotherapy or radiotherapy
- Complete or partial Dihydropyrimidine dehydrogenase deficiency
- Any infection jeopardizing treatment
- Serious other diseases affecting participation or safety
- History of inflammatory bowel disease
- History of pulmonary fibrosis or interstitial pneumonia
- Use of antivitamin K drugs unless switched to low molecular weight heparin before chemotherapy
- Known allergy to Capecitabine or related drugs
- Recent live attenuated vaccine within 10 days
- Pregnant or breastfeeding women
- Use of investigational drugs within last 30 days
- Under legal guardianship or similar protections
- Inability to undergo medical monitoring due to geographical, social, or psychological reasons
AI-Screening
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Trial Site Locations
Total: 30 locations
1
Institut Paoli Calmettes
Marseille, Bouches Du Rhône, France, 13009
Actively Recruiting
2
Hôpital Nord de Marseille
Marseille, Bouches Du Rhône, France, 13015
Not Yet Recruiting
3
Hôpital Européen de MARSEILLE
Marseille, Bouches-du-rhône, France, 13003
Actively Recruiting
4
CHU Besançon
Besançon, Doubs, France, 25030
Actively Recruiting
5
CHU de Bordeaux
Bordeaux, Gironde, France, 33600
Actively Recruiting
6
Insitut Régional du Cancer de Montpellier
Montpellier, Hérault, France, 34298
Actively Recruiting
7
CHU de Nancy
Vandœuvre-lès-Nancy, Lorraine, France, 54511
Actively Recruiting
8
Centre Alexis Vautrin
Nancy, Meurthe Et Moselle, France, 54519
Actively Recruiting
9
Centre Oscart Lambret
Lille, Nord, France, 59000
Actively Recruiting
10
CHU Amiens
Amiens, Picardie, France, 80054
Actively Recruiting
11
CHU Clermont-Ferrand
Clermont-Ferrand, Puy De Dôme, France, 63000
Actively Recruiting
12
CH PAU
Pau, Pyrénées-atlantiques, France, 64000
Actively Recruiting
13
CHU de Lyon
Lyon, Rhône, France, 69310
Actively Recruiting
14
CH Annecy
Annecy, Savoie, France, 74330
Not Yet Recruiting
15
CHU Rouen
Rouen, Seine-Maritime, France, 76031
Actively Recruiting
16
Hôpital Bicêtre
Le Kremlin-Bicêtre, Val De Marne, France, 94270
Actively Recruiting
17
Bordeaux Colorectal Institute
Bordeaux, France, 33300
Actively Recruiting
18
Centre Georges-François Leclerc
Dijon, France, 21079
Not Yet Recruiting
19
Chu Grenoble
Grenoble, France
Actively Recruiting
20
Chu Lille
Lille, France, 59037
Actively Recruiting
21
CAC Léon Bérard
Lyon, France
Actively Recruiting
22
Hôpital La Timone
Marseille, France, 13005
Actively Recruiting
23
Centre Antoine Lacassagne
Nice, France
Actively Recruiting
24
CHU de Nîmes
Nîmes, France, 30029
Actively Recruiting
25
Hôpital Saint-Louis
Paris, France, 75010
Actively Recruiting
26
Hôpital Saint-Antoine
Paris, France, 75012
Actively Recruiting
27
Hôpital Européen Georges-Pompidou
Paris, France, 75015
Actively Recruiting
28
Hôpital Diaconesses
Paris, France, 75020
Actively Recruiting
29
Institut de Cancérologie de l'Ouest
Saint-Herblain, France, 44800
Actively Recruiting
30
CHU de Toulouse
Toulouse, France, 31059
Actively Recruiting
Research Team
P
Philippe Rouanet, MD
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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