Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies
RECOURSE
Randomized, Double-blind, Phase 3 Study of TAS-102 Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies
2 other identifiers
interventional
800
12 countries
110
Brief Summary
The purpose of this study is to compare the efficacy and safety of TAS-102 versus placebo in patients with refractory metastatic colorectal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 colorectal-cancer
Started Jun 2012
110 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
May 24, 2012
CompletedFirst Posted
Study publicly available on registry
May 30, 2012
CompletedStudy Start
First participant enrolled
June 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 23, 2016
CompletedResults Posted
Study results publicly available
May 21, 2019
CompletedSeptember 19, 2024
August 1, 2024
1.6 years
May 24, 2012
April 1, 2019
August 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival
Overall survival was defined as the time from the date of randomization to the date of death for participants. If a participant discontinued study medication for reasons other than radiologic disease progression, the participant was followed for tumor response until radiologic disease progression or initiation of new anticancer therapy.
Every 8 weeks, up to 12 months after the last participant was randomized or until the target number of events (deaths) was met, whichever was later. (Overall survival data was collected till 24 Jan 2014 which was date of observation of the 571st death)
Secondary Outcomes (2)
Progression-free Survival
Every 8 weeks, up to 12 months after the last participant was randomized or until the date of the investigator-assessed radiological disease progression or death due to any cause,whichever was later. (Progression free survival cutoff: 31 Jan 2014)
Percentage of Participants With Adverse Events (AE), Treatment-Related AEs, Discontinuations, Serious Adverse Events (SAEs) and Deaths
From the time of signing the informed consent form until the period of participant follow up (30 days following after the administration of last dose of study medication or until initiation of new antitumor therapy, whichever was earlier
Study Arms (2)
TAS-102
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
35 mg/m2/dose, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria are met.
Placebo tablets, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria are met.
Eligibility Criteria
You may qualify if:
- Has provided written informed consent
- Has adenocarcinoma of the colon or rectum
- Has failed at least 2 prior regimens of standard chemotherapies for metastatic colorectal cancer
- ECOG performance status of 0 or 1
- Is able to take medications orally
- Has adequate organ function (bone marrow, kidney and liver)
- Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.
You may not qualify if:
- Certain serious illnesses or medical condition(s)
- Has had certain other recent treatment e.g. major surgery, anticancer therapy, extended field radiation, received investigational agent, within the specified time frames prior to study drug administration
- Has received TAS-102
- Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies
- Is a pregnant or lactating female
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (115)
Arizona Center for Cancer Care
Glendale, Arizona, 85306, United States
California Cancer Associates for Research and Excellence
Fresno, California, 93720, United States
Ronald H. Yanagihara, MD
Gilroy, California, 95020, United States
LAC and USC Medical Center
Los Angeles, California, 90033, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Pacific Hematology Oncology Associates
San Francisco, California, 94115, United States
San Jose Medical Group
San Jose, California, 95124, United States
Coastal Integrative Cancer Care
San Luis Obispo, California, 93401, United States
Yale Cancer Center
New Haven, Connecticut, 06520, United States
MD Anderson Cancer Center Orlando
Orlando, Florida, 32806, United States
Illinois Cancer Care, P.C.
Peoria, Illinois, 61615, United States
Indiana University Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809, United States
Ochsner Clinic Fndtn
New Orleans, Louisiana, 70121-2429, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
St. Joseph Mercy Hospital
Ann Arbor, Michigan, 48106, United States
Jefferson City Medical Group
Jefferson City, Missouri, 65109-6023, United States
Saint Luke's Cancer Institute
Kansas City, Missouri, 64111, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
Hickman Cancer Center at Flower Hospital
Sylvania, Ohio, 43560, United States
Hematology/Oncology Associates of Fredericksburg
Fredericksburg, Virginia, 22408, United States
Royal North Shore Hospital
Sydney, New South Wales, 2065, Australia
The Queen Elisabeth Hospital
Woodville South, South Australia, 5011, Australia
Austin Hospital
Heidelberg, Victoria, 3084, Australia
The Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Sir Charles Gairdner Hospital
Perth, Western Australia, 6009, Australia
Krankenhaus der Barmherzigen Schwestern Linz
Linz, 4010, Austria
Universitaet Wien
Vienna, 1090, Austria
Universitaetsklinik fur Innere Medizin
Vienna, 1090, Austria
Wilhelminenspital Wien
Vienna, 1160, Austria
Klinikum Wels-Grieskirchen GmbH
Wels, 4600, Austria
Cliniques Universitaires UCL St. Luc
Brussels, 1200, Belgium
Erasme University Hospital-ULB-Brussels
Brussels, B-1070, Belgium
Grand Hospital de Charleroi
Charleroi, 6000, Belgium
Antwerp University Hospital
Edegem, 2650, Belgium
University Hospital Gent
Edegem, 2650, Belgium
University Hospital Gent
Ghent, 9000, Belgium
Leuven University Hospital - Campus Gasthuiseberg
Leuven, 3000, Belgium
University Hospital Gasthuisberg
Leuven, 3000, Belgium
Klinika onkologie a radioteraie, Facultni nemocnice Hradec Kralove
Hradec Králové, 50005, Czechia
Institute of Oncology and Rehabilitation Ples
Nová Ves pod Pleší, 26204, Czechia
CHU de Becançon
Besançon, 25030, France
University Hospital of Bordeaux
Bordeaux, 33075, France
Centre Oscar Lambret
Lille, 59020, France
CRLC Val d'Aurelle
Montpellier, 34298, France
Hopital Saint Antoine
Paris, 75571, France
Centre Eugene Marquis
Rennes, 35042, France
Onkologische Schwerpunktpraxis Kurfuerstendamm
Berlin, 10707, Germany
Praxiskooperation Bonn-Euskirchen-Rheinbach
Bonn, 53123, Germany
Uniklinik Koeln
Cologne, 50937, Germany
Universitatsklinikum Carl Gustav Carus - Dresden
Dresden, 1307, Germany
Medizinische Klinik am Krankenhaus Nordwest GmbH
Frankfurt, 60488, Germany
Uniklinik der Martin-Luther-Universitaet Halle-Wittenberg
Halle, 6120, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246, Germany
Johannes Gutenberg Universität Mainz
Mainz, 55131, Germany
Interdisziplinaeres Tumorzentrum Mannheim
Mannheim, 68167, Germany
Klinikum der Universität München - Großhadern
München, 81377, Germany
Staedtisches Klinikum Muenchen / Klinikum Neuperlach
München, 81737, Germany
Klinikum Oldenburg gGmbH
Oldenburg, 26133, Germany
Universitaetsklinikum Ulm
Ulm, 89081, Germany
Bon Secours Hospital
Cork, Ireland
Adelaide and Meath Hospital
Dublin, 24, Ireland
St. Vincent's University Hospital
Dublin, 4, Ireland
Fondazione Poliambulanza
Brescia, Lombardy, 25124, Italy
Universita Delgi Studi de Genova (UNIGE)- Azienda Ospedaliera. Universitaria "San Martino" (Ospedale San Martino)
Genova, 16132, Italy
A.O. Ospedale Niguarda Ca' Granda
Milan, 20162, Italy
Fondazione IRCCS Instituto Nazionale dei Tumori Milano
Milan, 20133, Italy
A.O. R.N. "A.Cardarelli"
Naples, 80131, Italy
Seconda Universita degli Studi de Napoli
Napoli, 80131, Italy
AOU San Luidi di Orbassano
Orbassano, 1010043, Italy
Azienda Ospedaliero
Pisa, 6756126, Italy
Arcispidale S Maria Nuova
Reggio Emilia, 42123, Italy
Ospedale di Rimini
Rimini, 47923, Italy
Ospedale di Sondrio
Sondrio, 23100, Italy
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, 4648681, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, 277-0882, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, 2778577, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, 7910280, Japan
KKR Sapporo Medical Center TONAN-Hospital
Sapporo, Hokkaido, 0600001, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, 0608648, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 6500047, Japan
Tsukuba University Hospital
Tsukuba, Ibaraki, 3058576, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, 2418515, Japan
Osaka Medical College Hospital
Takatsuki, Osaka, 5698686, Japan
Saitama Cancer Center
Kita-adachi-gun, Saitama, 3620806, Japan
Shizuoka Cancer Center
Sunto-gun, Shizuoka, 4118777, Japan
Jichi Medical University Hospital
Shimotsuke, Tochigi, 3290498, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, 1040045, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, 1358550, Japan
Keio University Hospital
Shinjuku-ku, Tokyo, 1608582, Japan
Chiba Cancer Center
Chiba, 2608717, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, 8111395, Japan
Kumamoto University Hospital
Kumamoto, 8608556, Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka, 5378511, Japan
Tokushima University Hospital
Tokushima, 7708503, Japan
Hospital Universitario Vall d'Hebrón
Barcelona, 8035, Spain
Hospital Arnau de Vilanova
Lleida, 25198, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Fundacion Jimenez Diaz - Universidad Autonoma de Madrid
Madrid, 28040, Spain
Hospital 12 de Octubre
Madrid, 28041, Spain
Hospital Carlos Haya
Málaga, 29010, Spain
Hospital Universitario Morales Messeguer
Murcia, 30008, Spain
Corporacion Sanitaria Parc Tauli
Sabadell, 8916, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Hospital Clínico Universitario de Valencia
Valencia, 46010, Spain
Hospital General Universitario de Valencia
Valencia, 46014, Spain
Karolinska University Hospital
Stockholm, 17176, Sweden
Akademiska Sjukhuset
Uppsala, 75185, Sweden
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN, United Kingdom
University Hospitals Bristol NHS Foundation Trust
Bristol, BS2 8ED, United Kingdom
St James' Institute of Oncology
Leeds, LS9 7TF, United Kingdom
University College London Hospitals Foundation NHS Trust
London, NW1 2PG, United Kingdom
The Royal Marsden NHS Foundation Trust
Surrey, SM2 5PT, United Kingdom
Related Publications (4)
Yoshino T, Cleary JM, Van Cutsem E, Mayer RJ, Ohtsu A, Shinozaki E, Falcone A, Yamazaki K, Nishina T, Garcia-Carbonero R, Komatsu Y, Baba H, Argiles G, Tsuji A, Sobrero A, Yamaguchi K, Peeters M, Muro K, Zaniboni A, Sugimoto N, Shimada Y, Tsuji Y, Hochster HS, Moriwaki T, Tran B, Esaki T, Hamada C, Tanase T, Benedetti F, Makris L, Yamashita F, Lenz HJ. Neutropenia and survival outcomes in metastatic colorectal cancer patients treated with trifluridine/tipiracil in the RECOURSE and J003 trials. Ann Oncol. 2020 Jan;31(1):88-95. doi: 10.1016/j.annonc.2019.10.005.
PMID: 31912801DERIVEDVan Cutsem E, Mayer RJ, Laurent S, Winkler R, Gravalos C, Benavides M, Longo-Munoz F, Portales F, Ciardiello F, Siena S, Yamaguchi K, Muro K, Denda T, Tsuji Y, Makris L, Loehrer P, Lenz HJ, Ohtsu A; RECOURSE Study Group. The subgroups of the phase III RECOURSE trial of trifluridine/tipiracil (TAS-102) versus placebo with best supportive care in patients with metastatic colorectal cancer. Eur J Cancer. 2018 Feb;90:63-72. doi: 10.1016/j.ejca.2017.10.009. Epub 2017 Dec 21.
PMID: 29274618DERIVEDLongo-Munoz F, Argiles G, Tabernero J, Cervantes A, Gravalos C, Pericay C, Gil-Calle S, Mizuguchi H, Carrato-Mena A, Limon ML, Garcia-Carbonero R. Efficacy of trifluridine and tipiracil (TAS-102) versus placebo, with supportive care, in a randomized, controlled trial of patients with metastatic colorectal cancer from Spain: results of a subgroup analysis of the phase 3 RECOURSE trial. Clin Transl Oncol. 2017 Feb;19(2):227-235. doi: 10.1007/s12094-016-1528-7. Epub 2016 Jul 21.
PMID: 27443414DERIVEDMayer RJ, Van Cutsem E, Falcone A, Yoshino T, Garcia-Carbonero R, Mizunuma N, Yamazaki K, Shimada Y, Tabernero J, Komatsu Y, Sobrero A, Boucher E, Peeters M, Tran B, Lenz HJ, Zaniboni A, Hochster H, Cleary JM, Prenen H, Benedetti F, Mizuguchi H, Makris L, Ito M, Ohtsu A; RECOURSE Study Group. Randomized trial of TAS-102 for refractory metastatic colorectal cancer. N Engl J Med. 2015 May 14;372(20):1909-19. doi: 10.1056/NEJMoa1414325.
PMID: 25970050DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Taiho
- Organization
- Taiho Oncology, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
From - Boston, MA
Dana-Farber Cancer Institute
- PRINCIPAL INVESTIGATOR
From - Leuven, Belgium
University Hospital, Gasthuisberg
- PRINCIPAL INVESTIGATOR
From - Kashiwa, Chiba Japan
National Cancer Center Hospital East
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2012
First Posted
May 30, 2012
Study Start
June 17, 2012
Primary Completion
January 31, 2014
Study Completion
May 23, 2016
Last Updated
September 19, 2024
Results First Posted
May 21, 2019
Record last verified: 2024-08