A Phase III, Randomised, international trial comparing mFOLFIRINOX triplet chemotherapy to mFOLFOX for high-risk stage III colon cancer in adjuvant setting - IROCAS

Studio Clinico

Patologia: Tumori del colon retto

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: Sì

Fase di studio: III

Linee di trattamento: Adiuvante/neoadiuvante

Criteri di inclusione: 

1. Patient ≥18 years and <71 years
2. Patient with Eastern Cooperative Oncology Group (ECOG) ≤1
3. Pathologically confirmed high-risk stage III colon adenocarcinoma, restricted to pT4N1 or pT1-4N2 tumor
4. Curative R0 surgical resection within 42 days before randomization
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 ≥100 x 10⁹/L
    - Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤2.5 x ULN
    - Alkaline phosphatase ≤2.5 x upper limit of normal (ULN)
    - Total Bilirubin ≤1.5 x ULN
    - Creatinine clearance ≥50 mL/min (Cockcroft and Gault formula)
    - Kalemia, magnesemia, calcemia ≥1 lower limit of normal (LLN)
    - Carcinoembryonic antigen (CEA) ≤10 ng/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 ≥ 5 years

Criteri di esclusione: 

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: QT/QTc ≥450 msec, for women: QT/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. Known DPD deficiency or UGT1A1 homozygous 7/7
12. Patients already included in another therapeutic trial involving an experimental drug

Trattamento sperimentale: 

Arm A: mFOLFIRINOX

Trattamento di controllo: 

Arm B: mFOLFOX 6

Obiettivi primari dello studio: 

The primary objective is the 3-year Disease Free Survival rate.

Obiettivi secondari dello studio: 

- Evaluation of Efficacy: Disease-free-Survival at 2 years.
- Overall Survival (OS)
- Evaluation of Toxicity

Centri partecipanti

Nord Italia

Centro Italia

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2016-001491-29

Data di inserimento: 18.11.2019

Promotore

Gruppo Oncologico del Nord Ovest (GONO)

CRO

/

Principal Investigator ITALIA

AOU Pisana - PO Santa Chiara

Riferimento: Dr.ssa Chiara Cremolini

Telefono: 050992192

Email: chiaracremolini@gmail.com

Localita: Pisa