Informations générales (source: ClinicalTrials.gov)
A Phase III, Randomised, International Trial Comparing mFOLFIRINOX Triplet Chemotherapy to mFOLFOX for High-risk Stage III Colon Cancer in Adjuvant Setting (IROCAS)
Interventional
Phase 3
UNICANCER (Voir sur ClinicalTrials)
mars 2017
juin 2027
04 mai 2025
The trial is a phase III, multicenter, open-labeled randomized trial comparing the
association of 5-fluorouracil (5-FU), folinic acid, irinotecan, and oxaliplatin
(mFOLFIRINOX) versus oxaliplatin, folinic acid, and 5-FU (mFOLFOX 6) chemotherapy
protocols in patients with high-risk stage III colon cancer in the adjuvant setting.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Saint Antoine | 04/06/2024 14:01:35 | Contact (sur clinicalTrials) | |||
| CLCC INSTITUT GUSTAVE ROUSSY | Val�rie BOIGE | 22/02/2024 08:54:01 | Contacter | ||
| CLCC RENE HUGUENIN INSTITUT CURIE | 10/04/2025 13:12:02 | Contact (sur clinicalTrials) | |||
| HOPITAL FOCH | Asmahane BENMAZIANE TEILLET | 05/05/2025 07:11:57 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Europeen Georges Pompidou | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier Annecy Genevois - Pringy - France | Contact (sur clinicalTrials) | ||||
| Ch Emile Roux - Le Puy-en-Velay - France | Contact (sur clinicalTrials) | ||||
| CHD de Vendée - La Roche-sur-Yon - France | Contact (sur clinicalTrials) | ||||
| CHP Saint Grégoire - Saint Gregoire - France | Contact (sur clinicalTrials) | ||||
| Clinique de la Côte d'Emeraude - Saint-Malo - France | Contact (sur clinicalTrials) | ||||
| Hôpital privé Jean Mermoz - Lyon - France | Contact (sur clinicalTrials) | ||||
| Hospices civils de Lyon - Hôpital Edouard Herriot - Lyon - France | Contact (sur clinicalTrials) | ||||
| Icm Val D'Aurelle - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancérologie de l'Ouest -site Paul Papin - Angers - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancérologie de l'Ouest -site René Gauducheau - Nantes - France | Contact (sur clinicalTrials) | ||||
| Institut Jean Godinot - Reims - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
INCLUSION CRITERIA:
1. Patient ≥18 years and < 75 years
2. Patient ≥18 years and <71 years must have an ECOG ≤1 - Patients ≥71 years and < 75
years must have an ECOG = 0
3. Pathologically confirmed high-risk stage III colon adenocarcinoma, restricted to
pT4N1 or pT1-4N2 tumor.
4. Curative R0 surgical resection.
5. Patients who have undergone surgery for colon cancer, defined as a tumor location
>12 cm from the anal verge by endoscopy and/or above the peritoneal reflection at
surgery (high rectum), without gross or microscopic evidence of residual disease
after surgery with curative intent
6. Start of study drug treatment has to be performed less than 56 days after surgery.
7. No prior chemotherapy.
8. No prior abdominal or pelvic irradiation.
9. Patient with adequate organ function:
- Absolute neutrophil count (ANC) ≥ 2 x 109/L
- Haemoglobin ≥9 g/dL
- Platelets (PTL) ≥100 x 109/L
- AST/ALT ≤2.5 x ULN
- Alkaline phosphatase ≤2.5 x ULN
- Total Bilirubin ≤1.5 x ULN (Upper Limit of Normal)
- Creatinine clearance ≥50 mL/min (Cockcroft and Gault formula)
- Kalemia, magnesemia, calcemia ≥ 1 LLN (Lower Limit of Normal)
- Carcinoembryonic antigen (CEA) ≤10ng/mL after surgery (during screening period)
10. Adequate contraception if applicable.
11. Patient able and willing to comply with study procedures as per protocol
12. Patient able to understand and willing to sign and date the written voluntary
informed consent form at screening visit prior to any protocol-specific procedures
13. Public or private health insurance coverage
14. Life expectancy of > or = at 5 years
15. Uracilemia < 16 ng/ml (only for french centers)
1. Patient ≥18 years and < 75 years
2. Patient ≥18 years and <71 years must have an ECOG ≤1 - Patients ≥71 years and < 75
years must have an ECOG = 0
3. Pathologically confirmed high-risk stage III colon adenocarcinoma, restricted to
pT4N1 or pT1-4N2 tumor.
4. Curative R0 surgical resection.
5. Patients who have undergone surgery for colon cancer, defined as a tumor location
>12 cm from the anal verge by endoscopy and/or above the peritoneal reflection at
surgery (high rectum), without gross or microscopic evidence of residual disease
after surgery with curative intent
6. Start of study drug treatment has to be performed less than 56 days after surgery.
7. No prior chemotherapy.
8. No prior abdominal or pelvic irradiation.
9. Patient with adequate organ function:
- Absolute neutrophil count (ANC) ≥ 2 x 109/L
- Haemoglobin ≥9 g/dL
- Platelets (PTL) ≥100 x 109/L
- AST/ALT ≤2.5 x ULN
- Alkaline phosphatase ≤2.5 x ULN
- Total Bilirubin ≤1.5 x ULN (Upper Limit of Normal)
- Creatinine clearance ≥50 mL/min (Cockcroft and Gault formula)
- Kalemia, magnesemia, calcemia ≥ 1 LLN (Lower Limit of Normal)
- Carcinoembryonic antigen (CEA) ≤10ng/mL after surgery (during screening period)
10. Adequate contraception if applicable.
11. Patient able and willing to comply with study procedures as per protocol
12. Patient able to understand and willing to sign and date the written voluntary
informed consent form at screening visit prior to any protocol-specific procedures
13. Public or private health insurance coverage
14. Life expectancy of > or = at 5 years
15. Uracilemia < 16 ng/ml (only for french centers)
1. Major surgical procedure, open biopsy or significant traumatic injury within 28 days
prior to study treatment start. Incompletely healed wounds or anticipation of the
need for major surgical procedure during the course of the study
2. Metastatic disease
3. Presence of inflammatory bowel disease and/or ileus
4. Known hypersensitivity reaction to any of the components of study treatments.
5. Pregnancy (absence to be confirmed by β-hCG test) or breast-feeding period
6. Clinically relevant coronary artery disease or history of myocardial infarction in
the last 12 months, or high risk of uncontrolled arrhythmia (for men: QTc ≥450 msec,
for women: QTc ≥470 msec)
7. Previous malignancy in the last 5 years except curative treated basal cell carcinoma
of the skin and/or in situ carcinoma of the cervix
8. Medical, geographical, sociological, psychological or legal conditions that would
not permit the patient to complete the study or sign informed consent
9. History or current evidence on physical examination of central nervous system
disease or peripheral neuropathy ≥ grade 1 Common Toxicity Criteria for Adverse
Events (CTCAE) v4.03.
10. Any significant disease which, in the investigator's opinion, would exclude the
patient from the study.
11. Patient with a DPD deficiency or UGT1A1 homozygous 7/7; the test should be done for
all patients before 5-FU administration, according to ANSM communication regarding
recommendation about high risk of no testing DPD in patient before 5-FU
administration; (Appendices 8 to 11).
12. Patients already included in another therapeutic trial involving an experimental
drug