Phase 3
Completed N=800
Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies
Source: ClinicalTrials.gov NCT01607957 ↗Enrolled (actual)
800
Serious AEs
31.0%
Results posted
May 2019
Primary outcomePrimary: Overall Survival — 7.1; 5.3 months — p=<0.0001
◆ Published Evidence
Highly cited
1,439citations · ~131 / year
Randomized trial of TAS-102 for refractory metastatic colorectal cancer.
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.
Linked Publications (4)
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Randomized trial of TAS-102 for refractory metastatic colorectal cancer.
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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.
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Neutropenia and survival outcomes in metastatic colorectal cancer patients treated with trifluridine/tipiracil in the RECOURSE and J003 trials.
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
7.1; 5.3 | <0.0001 sig |
| SECONDARY Progression-free Survival |
2.0; 1.7 | <0.0001 sig |
| SECONDARY Percentage of Participants With Adverse Events (AE), Treatment-Related AEs, Discontinuations, Serious Adverse Events (SAEs) and Deaths |
98.3; 93.2; 85.7; 54.7; 69.4; 51.7 | — |
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
Data sourced from ClinicalTrials.gov (NCT01607957) 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.