The main purpose of this study is to evaluate the progression-free survival (PFS) in patients receiving S 95005 + bevacizumab (experimental arm) or capecitabine + bevacizumab (control arm) as first-line treatment for unresectable metastatic colorectal cancer in patients non-eligible for intensive therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
154
Patients were treated withTrifluridine/tipiracil + bevacizumab regimen until they met a discontinuation criterion.
Patients were treated with capecitabine+ bevacizumab regimen until they met a discontinuation criterion.
Progression Free Survival (PFS)
The progression free survival (PFS), defined as the time from the date of randomisation until the date of the investigator-assessed radiological disease progression or death due to any cause according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Progressive disease (PD) was defined at least a 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) and an absolute increase of at least 5 mm in the sum of lesions or the appearance of new lesions.
Time frame: Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)
Overall Response Rate (ORR)
As per RECIST v1.1, Complete Response (CR) was disappearance of all target lesions; Partial Response (PR) was at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The ORR was the proportion of patients who presented CR or PR with confirmation at subsequent time point or at least 4 weeks later.
Time frame: Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)
Duration of Response (DR)
The DR was calculated among patients with CR or PR as the time (months) from the first documentation of response to the first documentation of objective tumor progression or death due to any cause, whichever occurred first.
Time frame: Baseline and every 8 weeks (maximum follow-up duration: 16.6 months)
Disease Control Rate (DCR)
DCR was the proportion of patients with confirmed CR, PR or stable disease (SD) as best overall response. SD defined as neither sufficient decrease to qualify for PR nor sufficient increase to qualify for PD.
Time frame: Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)
Overall Survival (OS)
The OS was defined as the time from the date of randomisation to the date of death. If death was not confirmed, or patient was alive at study cut-off date, survival time was censored at the date of last follow-up or at the study cut-off date, whichever was earlier.
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Chris O'Brien Lifehouse Oncology
Camperdown, Australia
Austin Hospital Olivia Newton-John Cancer & Wellness Centre
Heidelberg, Australia
Western Health, Sunshine Hospital
Saint Albans, Australia
The Queen Elizabeth Hospital Haematology and Oncology Unit
Woodville, Australia
Grand Hôpital de Charleroi Oncologie-Hématologie
Charleroi, Belgium
UZ Leuven Campus Gasthuisberg Digestieve Oncologie
Leuven, Belgium
CHC Saint-Joseph Oncologie-Hématoimmunopathologie
Liège, Belgium
Hospital do Câncer de Barretos - Fundação Pio XII
Barretos, Brazil
Centro de Pesquisa Hospital de Caridade de Ijuí
Ijuí, Brazil
Instituto Nacional do Câncer - INCA Unidade de Pesquisa ClínicaInstituto Nacional do Câncer - INCA Unidade de Pesquisa Clínica
Rio de Janeiro, Brazil
...and 47 more locations
Time frame: Baseline up to death or study cut-off (maximum follow-up duration: 19.9 months)