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
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).
2 other identifiers
interventional
154
12 countries
57
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2016
Typical duration for phase_2
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2016
CompletedFirst Posted
Study publicly available on registry
April 19, 2016
CompletedStudy Start
First participant enrolled
April 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2018
CompletedResults Posted
Study results publicly available
April 16, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedAugust 20, 2024
July 1, 2024
1.7 years
February 24, 2016
January 15, 2019
July 24, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)
Secondary Outcomes (4)
Overall Response Rate (ORR)
Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)
Duration of Response (DR)
Baseline and every 8 weeks (maximum follow-up duration: 16.6 months)
Disease Control Rate (DCR)
Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)
Overall Survival (OS)
Baseline up to death or study cut-off (maximum follow-up duration: 19.9 months)
Study Arms (2)
Trifluridine/tipiracil + bevacizumab
EXPERIMENTALTrifluridine/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.
Capecitabine + bevacizumab
ACTIVE COMPARATORCapecitabine 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
Interventions
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.
Eligibility Criteria
You may qualify if:
- Written informed consent obtained.
- Has ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1 or 2 at the time of the randomisation.
- Has definitive histologically or cytologically confirmed adenocarcinoma of the colon or rectum.
- RAS status must have been determined (mutant or wild).
- Has at least one measurable metastatic lesion.
- No previous systemic anticancer therapy for unresectable metastatic colorectal cancer.
- Previous adjuvant (or neoadjuvant for patients with rectal cancer) chemotherapy is allowed only if if it has been completed more than 6 months before start of study treatment.
- Patient is not a candidate for combination chemotherapy with irinotecan or oxaliplatin, or for curative resection of metastatic lesions.
- Is able to take medication orally (i.e., no feeding tube).
- Has adequate organ function.
- Coagulation parameters in normal limit (or in therapeutic limit for patients treated with anticoagulant drugs).
- Women of childbearing potential must have been tested negative in a serum pregnancy test. Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use a highly effective method of birth control. Women and female partners using hormonal contraceptive must also use a barrier method.
You may not qualify if:
- Is a pregnant or lactating female.
- Has certain serious illness or serious medical condition(s) as described in the protocol.
- Has had certain other recent treatment e.g. major surgery, field radiation, received investigational agent, within the specified time frames prior to randomisation.
- Has previously received Trifluridine/tipiracil or history of allergic reactions attributed to compounds of similar composition to Trifluridine/tipiracil or any of its excipients.
- Has rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
- Has contra-indication to bevacizumab or capecitabine.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (57)
Chris O'Brien Lifehouse Oncology
Camperdown, NSW 2050, Australia
Austin Hospital Olivia Newton-John Cancer & Wellness Centre
Heidelberg, VIC 3084, Australia
Western Health, Sunshine Hospital
Saint Albans, VIC 3021, Australia
The Queen Elizabeth Hospital Haematology and Oncology Unit
Woodville, SA 5011, Australia
Grand Hôpital de Charleroi Oncologie-Hématologie
Charleroi, 6000, Belgium
UZ Leuven Campus Gasthuisberg Digestieve Oncologie
Leuven, 3000, Belgium
CHC Saint-Joseph Oncologie-Hématoimmunopathologie
Liège, 4000, Belgium
Hospital do Câncer de Barretos - Fundação Pio XII
Barretos, 14784-400, Brazil
Centro de Pesquisa Hospital de Caridade de Ijuí
Ijuí, 98700-000, Brazil
Instituto Nacional do Câncer - INCA Unidade de Pesquisa ClínicaInstituto Nacional do Câncer - INCA Unidade de Pesquisa Clínica
Rio de Janeiro, 20230-130, Brazil
Hospital de Base, Centro Intergrado de Pesquisa
São José do Rio Preto, 15090-000, Brazil
Instituto do Câncer do Estado de São Paulo - ICESP, Núcleo de Pesquisa
São Paulo, 01246-000, Brazil
Rigshospitalet - Dpt of Oncology
Copenhagen, 2100, Denmark
Odense Universitetshospital - Department of Oncology
Odense, 5000, Denmark
CHU Jean Minjoz, Service d'oncologie médicale
Besançon, 25030, France
Hôpital Saint Antoine, oncology department
Paris, 75012, France
Centre René Gauducheau, Oncologie Médicale
Saint-Herblain, 44805, France
Onkologische Schwerpunktpraxis Kurfürstendamm
Berlin, 10707, Germany
Schwerpunktpraxis für Hämatologie und Onkologie
Magdeburg, 39104, Germany
Städtisches Krankenhaus München Neuperlach, Klinik für Onkologie und Hämatologie
Munich, 81737, Germany
Fondazione Poliambulanza Istituto Ospedaliero, Clinical Oncology
Brescia, 25124, Italy
A.O.U. SanMartino-IST, Unità Operativa Oncologia Medica 1
Genova, 16132, Italy
A.O. Ospedale Niguarda Ca' Granda-Milano, Department of Onco-Haematology- Onoclogia Falck
Milan, 20162, Italy
Seconda Università degli Studi di Napoli, U.O.C. di Oncologia Medica ed Ematologia
Naples, 80131, Italy
.O.U. Pisana-Ospedale Santa Chiara, U.O. di Oncologia Medica 2
Pisa, 56126, Italy
AMC Academisch Medisch Centrum Medische Oncologie
Amsterdam, 1105 AZ, Netherlands
Amphia Ziekenhuis, Interne Geneeskunde/Oncologie, Langendijk 75
Breda, 4819 EV, Netherlands
Catharina Ziekenhuis, Interne Geneeskunde/Oncologie
Eindhoven, 5623 EJ, Netherlands
Martini Ziekenhuizen, Interne Geneeskunde/Oncologie, Van Swietenplein 1
Groningen, 9728 NT, Netherlands
Tergooi Hilversum, Medische Oncologie, Van Riebeeckweg 212
Hilversum, 1213 XZ, Netherlands
Zuyderland Medisch Centrum Interne Geneeskunde
Sittard, 6162 BG, Netherlands
Sint Antonius Ziekenhuis Interne Geneeskunde/Oncologie
Utrecht, 3543 CX, Netherlands
VieCurie Medisch Centrum, Interne Geneeskunde, Tegelseweg 210
Venlo, 5912 BL, Netherlands
Isala Klinieken, Medische oncologie, Dokter Van Heeweg 2
Zwolle, 8025 AB, Netherlands
Szpitale Pomorskie Sp. z o.o. Oddzial Onkologii i Radioterapii
Gdynia, 81-519, Poland
SP ZOZ Szpital Uniwersytecki w Krakowie Oddzial Kliniczny Onkologii
Krakow, 31-531, Poland
Centralny Szpital Kliniczny MSW Klinika Onkologii i Hematologii
Warsaw, 02-507, Poland
NZOZ MAGODENT Oddzial Onkologii Klinicznej / Chemioterapii
Warsaw, 04-125, Poland
Russian Cancer Research Center n.a. NN Blokhin
Moscow, 115478, Russia
Moscow City Oncology Hospital # 62, Chemotherapy
Moscow, 143423, Russia
Russian Cancer Research Center n.a. NN Blokhin, Department of Research for New Antitumour Medicines
Moscow, Russia
Scientific Centre for Specialized Medical Care (oncological)
Saint Petersburg, 197758, Russia
Hospital Valle de Hebrón, Servicio de Oncología
Barcelona, 08035, Spain
Hospital Universitario Reina Sofia, Deparatmento Oncología Médica
Córdoba, 14004, Spain
Instituto Catalan De Oncología, Hospitalet de Llobregat
L'Hospitalet de Llobregat, 08908, Spain
Hospital Universitario Gregorio Maranon
Madrid, 28007, Spain
Hospital Ramón y Cajal, Oncología Médica
Madrid, 28034, Spain
H. Universitario La Paz Oncología Médica
Madrid, 28046, Spain
Hospital General Universitario, Oncología Médica
Málaga, 29010, Spain
Complejo Hospitalario de Navarra, Oncología Médica
Pamplona, 31008, Spain
The Beatson West of Scotland Cancer Centre GI cancers
Glasgow, G12 0YN, United Kingdom
Leicester Royal Infirmary, The HOPE Clinical Trials Unit
Leicester, LE1 5WW, United Kingdom
Hammersmith Hospital
London, W12 0HS, United Kingdom
Imperial healthcare NHS Trust Charing Cross Hospital
London, W6 8RF, United Kingdom
Christie Hospital NHS Foundation Trust, GI & Endocrine
Manchester, M20 4BX, United Kingdom
Mount Vernon Hospital Department of Oncology
Northwood, HA6 2RN, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
Related Publications (2)
Van Cutsem E, Danielewicz I, Saunders MP, Pfeiffer P, Argiles G, Borg C, Glynne-Jones R, Punt CJA, Van de Wouw AJ, Fedyanin M, Stroyakovskiy D, Kroening H, Garcia-Alfonso P, Wasan H, Falcone A, Fougeray R, Egorov A, Amellal N, Moiseyenko V. First-line trifluridine/tipiracil + bevacizumab in patients with unresectable metastatic colorectal cancer: final survival analysis in the TASCO1 study. Br J Cancer. 2022 Jun;126(11):1548-1554. doi: 10.1038/s41416-022-01737-2. Epub 2022 Apr 19.
PMID: 35440667BACKGROUNDVan Cutsem E, Danielewicz I, Saunders MP, Pfeiffer P, Argiles G, Borg C, Glynne-Jones R, Punt CJA, Van de Wouw AJ, Fedyanin M, Stroyakovskiy D, Kroening H, Garcia-Alfonso P, Wasan H, Falcone A, Kanehisa A, Egorov A, Aubel P, Amellal N, Moiseenko V. Trifluridine/tipiracil plus bevacizumab in patients with untreated metastatic colorectal cancer ineligible for intensive therapy: the randomized TASCO1 study. Ann Oncol. 2020 Sep;31(9):1160-1168. doi: 10.1016/j.annonc.2020.05.024. Epub 2020 Jun 1.
PMID: 32497736DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Patrick Therasse
- Organization
- Institut de Recherches Internationales Servier (I.R.I.S.)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Van Custem, Prof
Leuven Cancer Institute, University Hospitals Leuven
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2016
First Posted
April 19, 2016
Study Start
April 29, 2016
Primary Completion
January 15, 2018
Study Completion
September 1, 2020
Last Updated
August 20, 2024
Results First Posted
April 16, 2019
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- After Marketing Authorisation in EEA or US if the study is used for the approval.
- Access Criteria
- Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data. Access can be requested for all interventional clinical studies: * used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: * sponsored by Servier * with a first patient enrolled as of 1 January 2004 onwards * for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.