A Study Evaluating S 95005 Plus Bevacizumab and Capecitabine Plus Bevacizumab in Patients With Previously Untreated Colorectal Cancer Who Are Non-eligible for Intensive Therapy (TASCO1)
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|ClinicalTrials.gov Identifier: NCT02743221|
Recruitment Status : Active, not recruiting
First Posted : April 19, 2016
Results First Posted : April 16, 2019
Last Update Posted : October 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Colorectal Cancer||Drug: Trifluridine/tipiracil + bevacizumab Drug: Capecitabine + bevacizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||154 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Randomised, Non-comparative Phase 2 Study Evaluating S 95005 (TAS-102) Plus Bevacizumab and Capecitabine Plus Bevacizumab in Patients With Previously Untreated Metastatic COlorectal Cancer Who Are Non-eligible for Intensive Therapy (TASCO1 Study).|
|Actual Study Start Date :||April 29, 2016|
|Actual Primary Completion Date :||January 15, 2018|
|Estimated Study Completion Date :||April 22, 2020|
Experimental: Trifluridine/tipiracil + bevacizumab
Trifluridine/tipiracil (S95005): film-coated tablets containing 15mg of trifluridine and 7.065mg of tipiracil hydrochloride, or 20mg of trifluridine and 9.42mg of tipiracil hydrochloride.
Bevacizumab: concentrate for solution for IV infusion containing 25mg/ml of bevacizumab.
Trifluridine/tipiracil was administered at 35 mg/m2/dose orally within 1 hour after completion of morning and evening meals, for 5 days on/2 days off, over 2 weeks, followed by a 14-day rest period, with bevacizumab administered intravenously at the dose of 5 mg/kg every 2 weeks at Day 1 and Day 15.This treatment cycle was repeated every 4 weeks.
Drug: Trifluridine/tipiracil + bevacizumab
Patients were treated withTrifluridine/tipiracil + bevacizumab regimen until they met a discontinuation criterion.
Active Comparator: Capecitabine + bevacizumab
Capecitabine was administered at 1250 mg/m² orally BID (bis in die)on Days 1-14 of each cycle, with bevacizumab (7.5 mg/kg, IV) administered on Day 1 of each cycle. This treatment cycle was repeated every 3 weeks
Drug: Capecitabine + bevacizumab
Patients were treated with capecitabine+ bevacizumab regimen until they met a discontinuation criterion.
- Progression Free Survival (PFS) [ Time Frame: Baseline and every 8 weeks (maximum follow-up duration: 17.9 months) ]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.
- Overall Response Rate (ORR) [ Time Frame: Baseline and every 8 weeks (maximum follow-up duration: 17.9 months) ]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.
- Duration of Response (DR) [ Time Frame: Baseline and every 8 weeks (maximum follow-up duration: 16.6 months) ]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.
- Disease Control Rate (DCR) [ Time Frame: Baseline and every 8 weeks (maximum follow-up duration: 17.9 months) ]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.
- Overall Survival (OS) [ Time Frame: Baseline up to death or study cut-off (maximum follow-up duration: 19.9 months) ]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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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02743221
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|Principal Investigator:||Eric Van Custem, Prof||Leuven Cancer Institute, University Hospitals Leuven|