Phase 3
Completed N=406
Study of Trifluridine/Tipiracil (TAS-102) in Patients With Metastatic Colorectal Cancer in Asia
Source: ClinicalTrials.gov NCT01955837 ↗Enrolled (actual)
406
Serious AEs
23.4%
Results posted
Nov 2020
Primary outcomePrimary: Overall Survival（OS） — 7.8; 7.1 Months — p=0.035
◆ Published Evidence
Highly cited
257citations · ~32 / year
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.
Summary
To compare the effects of TAS-102 with placebo in patients with metastatic colorectal cancer refractory or intolerable to standard chemotherapies.
Linked Publications
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival（OS） |
7.8; 7.1 | 0.035 sig |
| SECONDARY Progression-free Survival (PFS) |
2.0; 1.8 | <0.001 sig |
| SECONDARY Time to Treatment Failure (TTF) |
1.9; 1.8 | <0.001 sig |
| SECONDARY Overall Response Rate (ORR; Complete Response [CR] or Partial Response [PR] Using RECIST Criteria) |
1.1; 0.0 | 0.554 |
| SECONDARY Disease Control Rate (DCR; CR, PR, or Stable Disease) |
44.1; 14.6 | <0.001 sig |
| SECONDARY Duration of Response |
6.6; 0 | <0.001 sig |
| SECONDARY Safety and Tolerability Evaluation Will Focus on Adverse Events and Laboratory Assessments（Adverse Events） |
2; 15; 269; 120; 269; 118 | — |
| SECONDARY Safety and Tolerability Evaluation Will Focus on Adverse Events and Laboratory Assessments（Laboratory Assessments） |
209; 52; 48; 8; 190; 4 | — |
| SECONDARY Overall Survival（OS）(Wild Type KRAS) |
8.6; 7.4 | 0.083 |
| SECONDARY Overall Survival（OS）(Mutant Type KRAS) |
7.0; 6.5 | 0.228 |
| SECONDARY Progression-free Survival (PFS) (Wild Type KRAS) |
2.0; 1.8 | — |
| SECONDARY Progression-free Survival (PFS) (Mutant Type KRAS) |
2.2; 1.8 | — |
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
- 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.
Data sourced from ClinicalTrials.gov (NCT01955837) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.