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Colorectal CancerPhase 3RECOURSENCT01607957

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

A Phase 3 study testing TAS-102 in people with Colorectal Cancer, run by Taiho Oncology, Inc. at 115 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
TAS-102
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
800 participants
Where
115 sitesin 13 countries
Study dates
17 Jun 2012to 23 May 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

115 sites in 13 countries.

115 sites in 13 countries

United States23 sites

  • St. Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Hematology/Oncology Associates of Fredericksburg

    Fredericksburg, Virginia, 22408

  • California Cancer Associates for Research and Excellence

    Fresno, California, 93720

  • Ronald H. Yanagihara, MD

    Gilroy, California, 95020

  • Arizona Center for Cancer Care

    Glendale, Arizona, 85306

  • Indiana University Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Jefferson City Medical Group

    Jefferson City, Missouri, 65109-6023

  • Saint Luke's Cancer Institute

    Kansas City, Missouri, 64111

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • LAC and USC Medical Center

    Los Angeles, California, 90033

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Yale Cancer Center

    New Haven, Connecticut, 06520

  • Ochsner Clinic Fndtn

    New Orleans, Louisiana, 70121-2429

  • MD Anderson Cancer Center Orlando

    Orlando, Florida, 32806

  • Illinois Cancer Care, P.C.

    Peoria, Illinois, 61615

  • Pacific Hematology Oncology Associates

    San Francisco, California, 94115

  • San Jose Medical Group

    San Jose, California, 95124

  • Coastal Integrative Cancer Care

    San Luis Obispo, California, 93401

  • Hickman Cancer Center at Flower Hospital

    Sylvania, Ohio, 43560

Other trials in United States

Japan21 sites

  • Chiba Cancer Center

    Chiba, 2608717

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 1040045

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 8111395

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-0882

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 2778577

  • Saitama Cancer Center

    Kita-adachi-gun, Saitama, 3620806

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 6500047

  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research

    Koto-ku, Tokyo, 1358550

  • Kumamoto University Hospital

    Kumamoto, 8608556

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime, 7910280

  • Aichi Cancer Center Hospital

    Nagoya, Aichi-ken, 4648681

  • Osaka Medical Center for Cancer and Cardiovascular Diseases

    Osaka, 5378511

  • KKR Sapporo Medical Center TONAN-Hospital

    Sapporo, Hokkaido, 0600001

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 0608648

  • Jichi Medical University Hospital

    Shimotsuke, Tochigi, 3290498

  • Keio University Hospital

    Shinjuku-ku, Tokyo, 1608582

  • Shizuoka Cancer Center

    Sunto-gun, Shizuoka, 4118777

  • Osaka Medical College Hospital

    Takatsuki, Osaka, 5698686

  • Tokushima University Hospital

    Tokushima, 7708503

  • Tsukuba University Hospital

    Tsukuba, Ibaraki, 3058576

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, 2418515

Other trials in Japan

Germany13 sites

  • Onkologische Schwerpunktpraxis Kurfuerstendamm

    Berlin, 10707

  • Praxiskooperation Bonn-Euskirchen-Rheinbach

    Bonn, 53123

  • Uniklinik Koeln

    Cologne, 50937

  • Universitatsklinikum Carl Gustav Carus - Dresden

    Dresden, 1307

  • Medizinische Klinik am Krankenhaus Nordwest GmbH

    Frankfurt, 60488

  • Uniklinik der Martin-Luther-Universitaet Halle-Wittenberg

    Halle, 6120

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Johannes Gutenberg Universität Mainz

    Mainz, 55131

  • Interdisziplinaeres Tumorzentrum Mannheim

    Mannheim, 68167

  • Klinikum der Universität München - Großhadern

    München, 81377

  • Staedtisches Klinikum Muenchen / Klinikum Neuperlach

    München, 81737

  • Klinikum Oldenburg gGmbH

    Oldenburg, 26133

  • Universitaetsklinikum Ulm

    Ulm, 89081

Other trials in Germany

Italy11 sites

  • Fondazione Poliambulanza

    Brescia, Lombardy, 25124

  • Universita Delgi Studi de Genova (UNIGE)- Azienda Ospedaliera. Universitaria "San Martino" (Ospedale San Martino)

    Genova, 16132

  • A.O. Ospedale Niguarda Ca' Granda

    Milan, 20162

  • Fondazione IRCCS Instituto Nazionale dei Tumori Milano

    Milan, 20133

  • A.O. R.N. "A.Cardarelli"

    Naples, 80131

  • Seconda Universita degli Studi de Napoli

    Naples, 80131

  • AOU San Luidi di Orbassano

    Orbassano, 1010043

  • Azienda Ospedaliero

    Pisa, 6756126

  • Arcispidale S Maria Nuova

    Reggio Emilia, 42123

  • Ospedale di Rimini

    Rimini, 47923

  • Ospedale di Sondrio

    Sondrio, 23100

Other trials in Italy

Spain11 sites

  • Hospital Universitario Vall d'Hebrón

    Barcelona, 8035

  • Hospital Arnau de Vilanova

    Lleida, 25198

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Fundacion Jimenez Diaz - Universidad Autonoma de Madrid

    Madrid, 28040

  • Hospital 12 de Octubre

    Madrid, 28041

  • Hospital Carlos Haya

    Málaga, 29010

  • Hospital Universitario Morales Messeguer

    Murcia, 30008

  • Corporacion Sanitaria Parc Tauli

    Sabadell, 8916

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

  • Hospital General Universitario de Valencia

    Valencia, 46014

Other trials in Spain

Belgium8 sites

  • Cliniques Universitaires UCL St. Luc

    Brussels, 1200

  • Erasme University Hospital-ULB-Brussels

    Brussels, B-1070

  • Grand Hospital de Charleroi

    Charleroi, 6000

  • Antwerp University Hospital

    Edegem, 2650

  • University Hospital Gent

    Edegem, 2650

  • University Hospital Gent

    Ghent, 9000

  • Leuven University Hospital - Campus Gasthuiseberg

    Leuven, 3000

  • University Hospital Gasthuisberg

    Leuven, 3000

Other trials in Belgium

France6 sites

  • CHU de Becançon

    Besançon, 25030

  • University Hospital of Bordeaux

    Bordeaux, 33075

  • Centre Oscar Lambret

    Lille, 59020

  • CRLC Val d'Aurelle

    Montpellier, 34298

  • Hopital Saint Antoine

    Paris, 75571

  • Centre Eugene Marquis

    Rennes, 35042

Other trials in France

Australia5 sites

  • Austin Hospital

    Heidelberg, Victoria, 3084

  • The Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Sir Charles Gairdner Hospital

    Perth, Western Australia, 6009

  • Royal North Shore Hospital

    Sydney, New South Wales, 2065

  • The Queen Elisabeth Hospital

    Woodville South, South Australia, 5011

Other trials in Australia

Austria5 sites

  • Krankenhaus der Barmherzigen Schwestern Linz

    Linz, 4010

  • Universitaet Wien

    Vienna, 1090

  • Universitaetsklinik fur Innere Medizin

    Vienna, 1090

  • Wilhelminenspital Wien

    Vienna, 1160

  • Klinikum Wels-Grieskirchen GmbH

    Wels, 4600

Other trials in Austria

United Kingdom5 sites

  • Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZN

  • University Hospitals Bristol NHS Foundation Trust

    Bristol, BS2 8ED

  • St James' Institute of Oncology

    Leeds, LS9 7TF

  • University College London Hospitals Foundation NHS Trust

    London, NW1 2PG

  • The Royal Marsden NHS Foundation Trust

    Surrey, SM2 5PT

Other trials in United Kingdom

Ireland3 sites

  • Bon Secours Hospital

    Cork

  • Adelaide and Meath Hospital

    Dublin, 24

  • St. Vincent's University Hospital

    Dublin, 4

Other trials in Ireland

Czechia2 sites

  • Klinika onkologie a radioteraie, Facultni nemocnice Hradec Kralove

    Hradec Králové, 50005

  • Institute of Oncology and Rehabilitation Ples

    Nová Ves pod Pleší, 26204

Other trials in Czechia

Sweden2 sites

  • Karolinska University Hospital

    Stockholm, 17176

  • Akademiska Sjukhuset

    Uppsala, 75185

Other trials in Sweden

About this study

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

The purpose of this study is to compare the efficacy and safety of TAS-102 versus placebo in patients with refractory metastatic colorectal cancer.

Read the 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).

Being tested
TAS-102, Placebo
Keywords
Refractory, metastatic colorectal cancer
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAS-102Drug

    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.

  • PlaceboDrug

    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.

Study groups in NCT01607957
Study groupRoleWhat they receive
TAS-102ExperimentalNot described
Receives: Drug: TAS-102
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. 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.

    Measured: 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)

  2. 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.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2012 (estimated)
  2. Study start17 Jun 2012
  3. Primary completion31 Jan 2014
  4. Study completion23 May 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
800 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01607957
Sponsor's protocol ID
TPU-TAS-102-301
Other IDs
2012-000109-66
Acronym
RECOURSE
Status last verified
Aug 2024
First submitted
24 May 2012
Last updated
19 Sep 2024
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 31912801

  • 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.

    PubMed 29274618

  • 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.

    PubMed 27443414

  • 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.

    PubMed 25970050

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TAS-102 in people with Colorectal Cancer, run by Taiho Oncology, Inc. at 115 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 115 sites in United States, Japan, Germany, Italy, Spain and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01607957, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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