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 regimen as first-line treatment of metastatic colorectal cancer patients.
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 patients who receive any second-line therapy. In a sequential strategy, not all patients who progress after first-line chemotherapy are able to receive second-line treatment. Moreover, there is a correlation between the response rate to chemotherapy and the postchemotherapy radical resection rate of metastases. Therefore, a way to improve the outcome of metastatic colorectal cancer patients could be to administer a first-line regimen containing the three active agents.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
244
Irinotecan 180 mg/sqm on day 1 Leucovorin 100 mg/sqm on day 1 and day 2 5-fluorouracil 400 mg/sqm bolus followed by 5-fluorouracil 600 mg/sqm 22-hour continuous infusion on day 1 and day 2 Repeated every 2 weeks
Irinotecan 165 mg/sqm on day 1 Oxaliplatin 85 mg/sqm on day 1 Leucovorin 200 mg/sqm on day 1 5-fluorouracil 3200 mg/sqm 48-hour continuous infusion starting on day 1 Repeated every 2 weeks
Response rate (RR)
Responses are evaluated every 8 weeks according to WHO criteria. The determination of responses and progression was initially based on investigator-reported measurements; computed tomography scans of all responding patients and of patients with stable disease were subsequently subjected to external review by an independent panel.
Time frame: Responses are evaluated every 8 weeks according to WHO criteria and reviewed by an independent panel at the end of treatment (6 months)
Progression-free survival (PFS)
PFS is defined as the length of time from random assignment to disease progression or to death resulting from any cause, whichever occurred first, or to last contact.
Time frame: Progressions are evaluated every 8 weeks according to WHO criteria and reviewed by an independent panel at the end of follow up (36 months)
Overall survival (OS)
OS is defined as the length of time from random assignment to death or to last contact.
Time frame: For survival analysis participants are followed until death
Postchemotherapy radical (R0) surgical resection rate of metastases
Percentage of patients who undergo radical (R0) resection of metastases after achieving objective response to chemotherapy.
Time frame: Postchemotherapy radical (R0) surgical resection rate of metastases were evaluated every 8 weeks during treatment and during follow up (36 months)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
During the full lenght of first-line treatment, number of enrolled patients reporting adverse events is recorded. Adverse events are evaluated according to National Cancer Institute Common Toxicity Criteria version 2.0.
Time frame: Number of Participants with Adverse Events as a Measure of Safety and Tolerability were evaluated every 2 weeks during treatment and every 8 weeks during follow up (36 months)
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Ospedale Civile Ss. Antonio E Biagio Di Alessandria - Alessandria (Al) Oncologia Medica
Alessandria, Italy
A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona - Ancona (An) Oncologia Medica
Ancona, Italy
Ausl Della Valle D' Aosta (Ao) - Aosta (Ao) Oncologia Medica
Aosta, Italy
P.O. Zona Aretina - Ospedale S. Donato Di Arezzo - Arezzo (Ar) Oncologia Medica
Arezzo, Italy
Azienda Ospedale 'G.Rummo' - Benevento (Bn) Oncologia Medica
Benevento, Italy
Ospedale Degli Infermi Di Biella - Biella (Bi) Oncologia Medica
Biella, Italy
Ospedale S. Orsola F.B.F. - Brescia - Brescia (Bs) Oncologia Medica
Brescia, Italy
Stabilimento "Perrino" - Brindisi - Brindisi (Br) Oncologia Medica
Brindisi, Italy
Azienda Ospedaliera S. Elia - Caltanissetta (Cl) Oncologia Medica
Caltanissetta, Italy
Ospedale Versilia - Camaiore (Lu) Oncologia Medica
Camaiore, Italy
...and 38 more locations
Quality of life (QoL)
Quality of life is assessed at the beginning of each treatment cycle using the Quality of Life Questionnaire of the European Organisation for Research and Treatment of Cancer (version 2.0). The QLQ-C30 questionnaire was analyzed with the global health status/quality-of-life scale as the primary end point and the other 10 scales as secondary end points.
Time frame: Quality of life was evaluated every 2 weeks during treatment and every 8 weeks during follow up (36 months)