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Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies (RECOURSE)

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
TAS-102
Placebo
Sponsored by
Taiho Oncology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Refractory, metastatic colorectal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Has provided written informed consent
  2. Has adenocarcinoma of the colon or rectum
  3. Has failed at least 2 prior regimens of standard chemotherapies for metastatic colorectal cancer
  4. ECOG performance status of 0 or 1
  5. Is able to take medications orally
  6. Has adequate organ function (bone marrow, kidney and liver)
  7. 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.

Exclusion Criteria:

  1. Certain serious illnesses or medical condition(s)
  2. 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
  3. Has received TAS-102
  4. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies
  5. Is a pregnant or lactating female

Sites / Locations

  • Arizona Center for Cancer Care
  • California Cancer Associates for Research and Excellence
  • Ronald H. Yanagihara, MD
  • LAC and USC Medical Center
  • USC Norris Comprehensive Cancer Center
  • Pacific Hematology Oncology Associates
  • San Jose Medical Group
  • Coastal Integrative Cancer Care
  • Yale Cancer Center
  • MD Anderson Cancer Center Orlando
  • Illinois Cancer Care, P.C.
  • Indiana University Simon Cancer Center
  • Mary Bird Perkins Cancer Center
  • Ochsner Clinic Fndtn
  • Massachusetts General Hospital
  • Dana-Farber Cancer Institute
  • St. Joseph Mercy Hospital
  • Jefferson City Medical Group
  • Saint Luke's Cancer Institute
  • Dartmouth-Hitchcock Medical Center
  • Gabrail Cancer Center
  • Hickman Cancer Center at Flower Hospital
  • Hematology/Oncology Associates of Fredericksburg
  • Royal North Shore Hospital
  • The Queen Elisabeth Hospital
  • Austin Hospital
  • The Royal Melbourne Hospital
  • Sir Charles Gairdner Hospital
  • Krankenhaus der Barmherzigen Schwestern Linz
  • Klinikum Wels-Grieskirchen GmbH
  • Universitaet Wien
  • Universitaetsklinik fur Innere Medizin
  • Wilhelminenspital Wien
  • Cliniques Universitaires UCL St. Luc
  • Erasme University Hospital-ULB-Brussels
  • Grand Hospital de Charleroi
  • Antwerp University Hospital
  • University Hospital Gent
  • University Hospital Gent
  • Leuven University Hospital - Campus Gasthuiseberg
  • University Hospital Gasthuisberg
  • Klinika onkologie a radioteraie, Facultni nemocnice Hradec Kralove
  • Institute of Oncology and Rehabilitation Ples
  • CHU de Becançon
  • University Hospital of Bordeaux
  • Centre Oscar Lambret
  • CRLC Val d'Aurelle
  • Hopital Saint Antoine
  • Centre Eugene Marquis
  • Onkologische Schwerpunktpraxis Kurfuerstendamm
  • Praxiskooperation Bonn-Euskirchen-Rheinbach
  • Universitatsklinikum Carl Gustav Carus - Dresden
  • Medizinische Klinik am Krankenhaus Nordwest GmbH
  • Uniklinik der Martin-Luther-Universitaet Halle-Wittenberg
  • Universitätsklinikum Hamburg-Eppendorf
  • Uniklinik Koeln
  • Johannes Gutenberg Universität Mainz
  • Interdisziplinaeres Tumorzentrum Mannheim
  • Staedtisches Klinikum Muenchen / Klinikum Neuperlach
  • Klinikum der Universität München - Großhadern
  • Klinikum Oldenburg gGmbH
  • Universitaetsklinikum Ulm
  • Bon Secours Hospital
  • Adelaide and Meath Hospital
  • St. Vincent's University Hospital
  • Fondazione Poliambulanza
  • Universita Delgi Studi de Genova (UNIGE)- Azienda Ospedaliera. Universitaria "San Martino" (Ospedale San Martino)
  • Fondazione IRCCS Instituto Nazionale dei Tumori Milano
  • A.O. Ospedale Niguarda Ca' Granda
  • A.O. R.N. "A.Cardarelli"
  • Seconda Universita degli Studi de Napoli
  • AOU San Luidi di Orbassano
  • Azienda Ospedaliero
  • Arcispidale S Maria Nuova
  • Ospedale di Rimini
  • Ospedale di Sondrio
  • Aichi Cancer Center Hospital
  • National Cancer Center Hospital East
  • National Cancer Center Hospital East
  • National Hospital Organization Shikoku Cancer Center
  • KKR Sapporo Medical Center TONAN-Hospital
  • Hokkaido University Hospital
  • Kobe City Medical Center General Hospital
  • Tsukuba University Hospital
  • Kanagawa Cancer Center
  • Osaka Medical College Hospital
  • Saitama Cancer Center
  • Shizuoka Cancer Center
  • Jichi Medical University Hospital
  • National Cancer Center Hospital
  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research
  • Keio University Hospital
  • Chiba Cancer Center
  • National Hospital Organization Kyushu Cancer Center
  • Kumamoto University Hospital
  • Osaka Medical Center for Cancer and Cardiovascular Diseases
  • Tokushima University Hospital
  • Hospital Universitario Vall d'Hebrón
  • Hospital Arnau de Vilanova
  • Hospital Universitario Ramon y Cajal
  • Fundacion Jimenez Diaz - Universidad Autonoma de Madrid
  • Hospital 12 de Octubre
  • Hospital Carlos Haya
  • Hospital Universitario Morales Messeguer
  • Corporacion Sanitaria Parc Tauli
  • Hospital Universitario Virgen del Rocio
  • Hospital Clínico Universitario de Valencia
  • Hospital General Universitario de Valencia
  • Karolinska University Hospital
  • Akademiska Sjukhuset
  • Aberdeen Royal Infirmary
  • University Hospitals Bristol NHS Foundation Trust
  • St James' Institute of Oncology
  • University College London Hospitals Foundation NHS Trust
  • The Royal Marsden NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TAS-102

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Progression-free Survival
Tumor assessments were performed throughout the study based on RECIST, Version 1.1, 2009. Progression free survival was defined as the time (in months) from the date of randomization until the date of the investigator-assessed radiological disease progression or death due to any cause. For participants who were alive with no radiological disease progression as of the analysis cut-off date, their survival was censored at the date of the last tumor assessment. Participants who received non-study cancer treatment before disease progression, or participants with clinical but not radiologic evidence of progression, were censored at the date of the last radiologic evaluable tumor assessment before the non-study cancer treatment was initiated.
Percentage of Participants With Adverse Events (AE), Treatment-Related AEs, Discontinuations, Serious Adverse Events (SAEs) and Deaths
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-related AEs were events between administration of study drug and up to 30 Days that were absent before treatment or that worsened relative to pre-treatment state. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability /incapacity; congenital anomaly. The AEs were graded for severity using National Cancer Institute Common Terminology Criteria for AEs.

Full Information

First Posted
May 24, 2012
Last Updated
June 1, 2020
Sponsor
Taiho Oncology, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01607957
Brief Title
Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies
Acronym
RECOURSE
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
June 17, 2012 (Actual)
Primary Completion Date
January 31, 2014 (Actual)
Study Completion Date
May 23, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taiho Oncology, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
This is a multinational, double-blind, two-arm, parallel, randomized Phase 3 comparison study evaluating the efficacy and safety of TAS-102 versus placebo in patients with refractory metastatic colorectal cancer. Patients will be randomly assigned (2:1) to TAS-102 (experimental arm) or placebo (control arm).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Refractory, metastatic colorectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
800 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAS-102
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
TAS-102
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Survival
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Progression-free Survival
Description
Tumor assessments were performed throughout the study based on RECIST, Version 1.1, 2009. Progression free survival was defined as the time (in months) from the date of randomization until the date of the investigator-assessed radiological disease progression or death due to any cause. For participants who were alive with no radiological disease progression as of the analysis cut-off date, their survival was censored at the date of the last tumor assessment. Participants who received non-study cancer treatment before disease progression, or participants with clinical but not radiologic evidence of progression, were censored at the date of the last radiologic evaluable tumor assessment before the non-study cancer treatment was initiated.
Time Frame
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)
Title
Percentage of Participants With Adverse Events (AE), Treatment-Related AEs, Discontinuations, Serious Adverse Events (SAEs) and Deaths
Description
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-related AEs were events between administration of study drug and up to 30 Days that were absent before treatment or that worsened relative to pre-treatment state. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability /incapacity; congenital anomaly. The AEs were graded for severity using National Cancer Institute Common Terminology Criteria for AEs.
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
From - Boston, MA
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
From - Leuven, Belgium
Organizational Affiliation
University Hospital, Gasthuisberg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
From - Kashiwa, Chiba Japan
Organizational Affiliation
National Cancer Center Hospital East
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Center for Cancer Care
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
California Cancer Associates for Research and Excellence
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Ronald H. Yanagihara, MD
City
Gilroy
State/Province
California
ZIP/Postal Code
95020
Country
United States
Facility Name
LAC and USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
USC Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Pacific Hematology Oncology Associates
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
San Jose Medical Group
City
San Jose
State/Province
California
ZIP/Postal Code
95124
Country
United States
Facility Name
Coastal Integrative Cancer Care
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93401
Country
United States
Facility Name
Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
MD Anderson Cancer Center Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Illinois Cancer Care, P.C.
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Indiana University Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Mary Bird Perkins Cancer Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Ochsner Clinic Fndtn
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121-2429
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
St. Joseph Mercy Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Jefferson City Medical Group
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109-6023
Country
United States
Facility Name
Saint Luke's Cancer Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Hickman Cancer Center at Flower Hospital
City
Sylvania
State/Province
Ohio
ZIP/Postal Code
43560
Country
United States
Facility Name
Hematology/Oncology Associates of Fredericksburg
City
Fredericksburg
State/Province
Virginia
ZIP/Postal Code
22408
Country
United States
Facility Name
Royal North Shore Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
The Queen Elisabeth Hospital
City
Woodville South
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Austin Hospital
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
The Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Krankenhaus der Barmherzigen Schwestern Linz
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
Klinikum Wels-Grieskirchen GmbH
City
Wels
ZIP/Postal Code
4600
Country
Austria
Facility Name
Universitaet Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Universitaetsklinik fur Innere Medizin
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Wilhelminenspital Wien
City
Wien
ZIP/Postal Code
1160
Country
Austria
Facility Name
Cliniques Universitaires UCL St. Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Erasme University Hospital-ULB-Brussels
City
Brussels
ZIP/Postal Code
B-1070
Country
Belgium
Facility Name
Grand Hospital de Charleroi
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
Antwerp University Hospital
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
University Hospital Gent
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
University Hospital Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Leuven University Hospital - Campus Gasthuiseberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
University Hospital Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Klinika onkologie a radioteraie, Facultni nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czechia
Facility Name
Institute of Oncology and Rehabilitation Ples
City
Nova Ves pod Plesi
ZIP/Postal Code
26204
Country
Czechia
Facility Name
CHU de Becançon
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
University Hospital of Bordeaux
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
CRLC Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Hopital Saint Antoine
City
Paris cedex 12
ZIP/Postal Code
75571
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes cedex
ZIP/Postal Code
35042
Country
France
Facility Name
Onkologische Schwerpunktpraxis Kurfuerstendamm
City
Berlin
ZIP/Postal Code
10707
Country
Germany
Facility Name
Praxiskooperation Bonn-Euskirchen-Rheinbach
City
Bonn
ZIP/Postal Code
53123
Country
Germany
Facility Name
Universitatsklinikum Carl Gustav Carus - Dresden
City
Dresden
ZIP/Postal Code
1307
Country
Germany
Facility Name
Medizinische Klinik am Krankenhaus Nordwest GmbH
City
Frankfurt
ZIP/Postal Code
60488
Country
Germany
Facility Name
Uniklinik der Martin-Luther-Universitaet Halle-Wittenberg
City
Halle (Saale)
ZIP/Postal Code
6120
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Uniklinik Koeln
City
Koeln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Johannes Gutenberg Universität Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Interdisziplinaeres Tumorzentrum Mannheim
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Staedtisches Klinikum Muenchen / Klinikum Neuperlach
City
Muenchen
ZIP/Postal Code
81737
Country
Germany
Facility Name
Klinikum der Universität München - Großhadern
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Klinikum Oldenburg gGmbH
City
Oldenburg
ZIP/Postal Code
26133
Country
Germany
Facility Name
Universitaetsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Bon Secours Hospital
City
Cork
Country
Ireland
Facility Name
Adelaide and Meath Hospital
City
Dublin
ZIP/Postal Code
24
Country
Ireland
Facility Name
St. Vincent's University Hospital
City
Dublin
ZIP/Postal Code
4
Country
Ireland
Facility Name
Fondazione Poliambulanza
City
Brescia
State/Province
Lombardy
ZIP/Postal Code
25124
Country
Italy
Facility Name
Universita Delgi Studi de Genova (UNIGE)- Azienda Ospedaliera. Universitaria "San Martino" (Ospedale San Martino)
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Fondazione IRCCS Instituto Nazionale dei Tumori Milano
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
A.O. Ospedale Niguarda Ca' Granda
City
Milan
ZIP/Postal Code
20162
Country
Italy
Facility Name
A.O. R.N. "A.Cardarelli"
City
Naples
ZIP/Postal Code
80131
Country
Italy
Facility Name
Seconda Universita degli Studi de Napoli
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
AOU San Luidi di Orbassano
City
Orbassano
ZIP/Postal Code
1010043
Country
Italy
Facility Name
Azienda Ospedaliero
City
Pisa
ZIP/Postal Code
6756126
Country
Italy
Facility Name
Arcispidale S Maria Nuova
City
Reggio Emilia
ZIP/Postal Code
42123
Country
Italy
Facility Name
Ospedale di Rimini
City
Rimini
ZIP/Postal Code
47923
Country
Italy
Facility Name
Ospedale di Sondrio
City
Sondrio
ZIP/Postal Code
23100
Country
Italy
Facility Name
Aichi Cancer Center Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
4648681
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-0882
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
2778577
Country
Japan
Facility Name
National Hospital Organization Shikoku Cancer Center
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
7910280
Country
Japan
Facility Name
KKR Sapporo Medical Center TONAN-Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
0600001
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
0608648
Country
Japan
Facility Name
Kobe City Medical Center General Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
6500047
Country
Japan
Facility Name
Tsukuba University Hospital
City
Tsukuba
State/Province
Ibaraki
ZIP/Postal Code
3058576
Country
Japan
Facility Name
Kanagawa Cancer Center
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
2418515
Country
Japan
Facility Name
Osaka Medical College Hospital
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
5698686
Country
Japan
Facility Name
Saitama Cancer Center
City
Kita-adachi-gun
State/Province
Saitama
ZIP/Postal Code
3620806
Country
Japan
Facility Name
Shizuoka Cancer Center
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
4118777
Country
Japan
Facility Name
Jichi Medical University Hospital
City
Shimotsuke
State/Province
Tochigi
ZIP/Postal Code
3290498
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
1040045
Country
Japan
Facility Name
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
1358550
Country
Japan
Facility Name
Keio University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
1608582
Country
Japan
Facility Name
Chiba Cancer Center
City
Chiba
ZIP/Postal Code
2608717
Country
Japan
Facility Name
National Hospital Organization Kyushu Cancer Center
City
Fukuoka
ZIP/Postal Code
8111395
Country
Japan
Facility Name
Kumamoto University Hospital
City
Kumamoto
ZIP/Postal Code
8608556
Country
Japan
Facility Name
Osaka Medical Center for Cancer and Cardiovascular Diseases
City
Osaka
ZIP/Postal Code
5378511
Country
Japan
Facility Name
Tokushima University Hospital
City
Tokushima
ZIP/Postal Code
7708503
Country
Japan
Facility Name
Hospital Universitario Vall d'Hebrón
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Hospital Arnau de Vilanova
City
Lleida
ZIP/Postal Code
25198
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Fundacion Jimenez Diaz - Universidad Autonoma de Madrid
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Carlos Haya
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Morales Messeguer
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Facility Name
Corporacion Sanitaria Parc Tauli
City
Sabadell
ZIP/Postal Code
8916
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Clínico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Facility Name
Akademiska Sjukhuset
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
University Hospitals Bristol NHS Foundation Trust
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
St James' Institute of Oncology
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
University College London Hospitals Foundation NHS Trust
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust
City
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
31912801
Citation
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.
Results Reference
derived
PubMed Identifier
29274618
Citation
Van 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.
Results Reference
derived
PubMed Identifier
27443414
Citation
Longo-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.
Results Reference
derived
PubMed Identifier
25970050
Citation
Mayer 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.
Results Reference
derived

Learn more about this trial

Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies

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