Study of Trifluridine/Tipiracil (TAS-102) in Patients With Metastatic Colorectal Cancer in Asia
TERRA
Randomized, Double-Blind, Phase III Study of TAS-102 Versus Placebo in Asian Patients With Metastatic Colorectal Cancer Refractory or Intolerable to Standard Chemotherapies
1 other identifier
interventional
406
3 countries
4
Brief Summary
To compare the effects of TAS-102 with placebo in patients with metastatic colorectal cancer refractory or intolerable to standard chemotherapies.
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 Sep 2013
Shorter than P25 for phase_3 colorectal-cancer
4 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
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 19, 2013
CompletedFirst Posted
Study publicly available on registry
October 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 16, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2016
CompletedResults Posted
Study results publicly available
November 17, 2020
CompletedNovember 17, 2020
October 1, 2020
2.5 years
September 19, 2013
May 28, 2020
October 23, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival（OS）
The primary endpoint was Overall Survival (OS), which was defined as the time from random assignment to the date of death. In the absence of confirmation of death or for patients alive at the OS cutoff date, survival time was censored at the date of last trial follow-up or the cutoff date, whichever was earlier.
Every 8 weeks. Survival status should be collected for up to 12 months after the last patient is randomized or until the target number of events (deaths) is met, whichever is later.
Secondary Outcomes (11)
Progression-free Survival (PFS)
Every 8 weeks. Tumor assessments will be performed until radiologic progression develops or the start of new anticancer treatment, for up to 12 months after the last patient is randomized or until the target number of events (deaths) is met.
Time to Treatment Failure (TTF)
From randomization until the date of radiologic disease progression, permanent discontinuation of study treatment, or death due to any cause, assessed up to 30 months.
Overall Response Rate (ORR; Complete Response [CR] or Partial Response [PR] Using RECIST Criteria)
From randomization until the date of radiologic disease progression, permanent discontinuation of study treatment, or death due to any cause, assessed up to 30 months.
Disease Control Rate (DCR; CR, PR, or Stable Disease)
From randomization until the date of radiologic disease progression, permanent discontinuation of study treatment, or death due to any cause, assessed up to 30 months.
Duration of Response
From randomization until the date of radiologic disease progression, permanent discontinuation of study treatment, or death due to any cause, assessed up to 30 months.
- +6 more secondary outcomes
Study Arms (2)
TAS-102
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
TAS-102 (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 is met.
Placebo 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 is 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
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Is able to take medication 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Peking University Cancer Hospital
Beijing, 100142, China
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
Asan Medical Center
Seoul, 138-736, South Korea
Chulalongkorn University & The King Chulalongkorn Memorial Hospital
Bangkok, 10330, Thailand
Related Publications (1)
Xu J, Kim TW, Shen L, Sriuranpong V, Pan H, Xu R, Guo W, Han SW, Liu T, Park YS, Shi C, Bai Y, Bi F, Ahn JB, Qin S, Li Q, Wu C, Ma D, Lin D, Li J. Results of a Randomized, Double-Blind, Placebo-Controlled, Phase III Trial of Trifluridine/Tipiracil (TAS-102) Monotherapy in Asian Patients With Previously Treated Metastatic Colorectal Cancer: The TERRA Study. J Clin Oncol. 2018 Feb 1;36(4):350-358. doi: 10.1200/JCO.2017.74.3245. Epub 2017 Dec 7.
PMID: 29215955DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Taiho Pharmaceutical Co., Ltd.
- Organization
- Clinical Trial Registration Contact
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2013
First Posted
October 8, 2013
Study Start
September 1, 2013
Primary Completion
February 16, 2016
Study Completion
June 30, 2016
Last Updated
November 17, 2020
Results First Posted
November 17, 2020
Record last verified: 2020-10