Status:
COMPLETED
FOLFOXIRI Compared With FOLFIRI for Metastatic Colorectal Cancer
Lead Sponsor:
Gruppo Oncologico del Nord-Ovest
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to evaluate if the exposure to all the three active cytotoxic agents (FOLFOXIRI regimen) is superior in terms of response rate to conventional chemotherapy with the FOLFIRI...
Detailed Description
Survival of patients with metastatic colorectal cancer is correlated with the proportion of patients who receive all the three active drugs in the course of the disease, but not with the proportion of...
Eligibility Criteria
Inclusion
- adenocarcinoma of the colon or rectum
- unresectable metastatic disease
- age 18 to 75 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower if age 70 years or younger or ECOG performance status of 0 if age 71 to 75 years measurable disease according to WHOcriteria
- leukocyte count of at least 3,500/mm3, neutrophils count of at least 1,500/mm3, platelet count of at least 100,000/mm3
- serum creatinine of 1.3 mg/dL or less
- serum bilirubin less than 1.5 mg/dL and AST, ALT, and alkaline phosphatase 2.5 x normal values or less (\</= 5 if liver metastases)
- previous fluoropyrimidine-based adjuvant chemotherapy was allowed if ended more than 6 months before random assignment
Exclusion
- previous palliative chemotherapy for metastatic disease
- previous chemotherapy including irinotecan or oxaliplatin
- symptomatic cardiac disease, myocardial infarction in the last 24 months or uncontrolled arrhythmia
- active infections
- inflammatory bowel disease
- total colectomy
Key Trial Info
Start Date :
November 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT01219920
Start Date
November 1 2001
End Date
November 1 2009
Last Update
March 11 2015
Active Locations (48)
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1
Ospedale Civile Ss. Antonio E Biagio Di Alessandria - Alessandria (Al) Oncologia Medica
Alessandria, Italy, 15100
2
A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona - Ancona (An) Oncologia Medica
Ancona, Italy, 60100
3
Ausl Della Valle D' Aosta (Ao) - Aosta (Ao) Oncologia Medica
Aosta, Italy, 11100
4
P.O. Zona Aretina - Ospedale S. Donato Di Arezzo - Arezzo (Ar) Oncologia Medica
Arezzo, Italy, 52100