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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: 

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

Fondazione Poliambulanza Istituto Ospedaliero
Via Bissolati 57 - 25124 Brescia - BS
UO Oncologia Medica

 

Azienda Ospedaliera S. Croce e Carle di Cuneo
Via Michele Coppino 26 - 12100 Cuneo - CN
S.C. Oncologia

 

E.O. OSPEDALI GALLIERA - GENOVA
Via Mura delle Cappuccine 14 - 16128 Genova - GE
S.C. Oncologia Medica - Via Volta 6

 

IRCCS A.O.U. San Martino - IST
Largo Rosanna Benzi 10 - 16132 Genova - GE
Clinica di medicina interna a indirizzo oncologico

 

IRCCS Istituto Nazionale dei Tumori
Via Venezian 1 - 20133 Milano - MI
Oncologia Medica 1

 

Istituto Oncologico Veneto IRCCS
Via Gattamelata 64 - 35128 Padova - PD
Oncologia Medica 1

 

Ospedale di Vicenza
Viale Rodolfi 37 - 36100 Vicenza - VI
U.O.C. Oncologia

 

Centro Italia

AOU Careggi
Largo Brambilla 3 - 50134 Firenze - FI
Oncologia Medica

Riferimento: Dr. Lorenzo Antonuzzo
Telefono: 0557949185
Email: antonuzzol@aou-careggi.toscana.it

 

Polo Oncologico Provinciale Frosinone
Via A. Fabi - 03100 Frosinone - FR
U.O.C. Oncologia

 

Azienda USL 6 Livorno
Viale Alfieri 36 - 57124 Livorno - LI
Ospedali Riuniti di Livorno - UOC Oncologia Medica

Riferimento: Dr. Giacomo Allegrini
Telefono: 0586223416
Email: giacomo.allegrini@uslnordovest.toscana.it

 

AOU Pisana - Santa Chiara
Via Roma 67 - 56126 Pisa - PI
UO Oncologia Medica 2 Universitaria

Riferimento: Dr.ssa Chiara Cremolini
Telefono: 050992192
Email: chiaracremolini@gmail.com

 

Nuovo Ospedale di Prato
Via Suor Niccolina Infermiera 20 - 59100 Prato - PO
Oncologia Medica

 

AOU Policlinico Tor Vergata
Viale Oxford 81 - 00133 Roma - RM
U.O.S.D. Oncologia Medica

 

Fondazione Policlinico A. Gemelli
Largo Agostino Gemelli 8 - 00168 Roma - RM
Oncologia Medica

 

Ospedale San Giovanni Calibita Fatebenefratelli
Via di Ponte Quattro Capi 39 - 00186 Roma - RM
U.O.C. Oncologia

 

Università Campus Bio-medico
Via Álvaro del Portillo 200 - 00128 Roma - RM
Dipartimento di Oncologia Medica

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

 

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