Trial · NCT01955837
Study of Trifluridine/Tipiracil (TAS-102) in Patients With Metastatic Colorectal Cancer in Asia
NCT01955837, Phase 3, Completed, Taiho Pharmaceutical Co., Ltd.; results first posted 2020-11-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Trifluridine/Tipiracil (TAS-102) in Patients With Metastatic Colorectal Cancer in Asia. Trials, record NCT01955837. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01955837
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Trifluridine/Tipiracil (TAS-102) in Patients With Metastatic Colorectal Cancer in Asia
- NCT number
- NCT01955837
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 406 participants, actual
- Lead sponsor
- Taiho Pharmaceutical Co., Ltd.
- Conditions
- Colorectal Cancer
- Interventions
- TAS-102, Placebo
- First posted
- 2013-10-08
- Last updated
- 2020-11-17
- Results first posted
- 2020-11-17
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival（OS） | 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. | 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. |
| Secondary | 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. | Tumor assessments were performed throughout the study period and analyzed using Response Evaluation Criteria in Solid Tumors criteria (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. Patients who received non-study cancer treatment before radiologic evidence of disease progression were censored at the date of the last evaluable tumor assessment before initiation of non-study cancer treatment. |
| Secondary | 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. | Time to treatment failure was defined as the time (in months) from the date of randomization until the date of radiologic disease progression, permanent discontinuation of study treatment, or death due to any cause. Censoring for TTF was also applied for those patients who were given non-study cancer treatment, with censoring at the time when the patient began the non-study cancer treatment. |
| Secondary | 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. | The assessment of ORR was based on Investigator review of the images according to RECIST Version 1.1. Overall response rate was defined as the proportion of patients with objective evidence of complete response (CR) or partial response (PR). At the analysis stage, the best overall response was assigned for each patient as the best response recorded from all responses recorded after study randomization. If applicable, responses recorded after disease progression or initiation of non-study cancer treatment was excluded. A patient's best response assignment of stable disease (SD) needed to be maintained for at least 6 weeks after study randomization. If a patient didn't meet this condition, best response was assigned "Not evaluable". |
| Secondary | 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. | The assessment of DCR paralleled that of ORR, with DCR defined as the proportion of patients with objective evidence of CR, PR, or SD. |
| Secondary | 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. | Duration of response was derived for those patients with objective evidence of PR or CR. Duration of response was defined as the time from the first documentation of response (CR or PR) to the first documentation of objective tumor progression or to death due to any cause. Patients alive and progression free as of the analysis cut-off date were censored at their last evaluable tumor response assessment prior to initiation of any non-study cancer treatment. |
| Secondary | Safety and Tolerability Evaluation Will Focus on Adverse Events and Laboratory Assessments（Adverse Events） | From the time a patient signed informed until 30 day safety follow-up visit or until initiation of new anticancer treatment, or assessed up to 30 months. | 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. |
| Secondary | Safety and Tolerability Evaluation Will Focus on Adverse Events and Laboratory Assessments（Laboratory Assessments） | From the time a patient signed informed until 30 day safety follow-up visit or until initiation of new anticancer treatment, or assessed up to 30 months. | All laboratory values that were out of the normal range were to be evaluated for their clinical significance before exposing the patient to the next dose of study medication. Any laboratory abnormality that was clinically significant, e.g., results in delay of study medication dosing, study discontinuation, required treatment due to abnormal values, or was considered by the Investigator to be medical important, were to be reported as an AE, unless it was considered part of clinical manifestations to a clinical diagnosis that has already been reported as an AE. |
| Secondary | Overall Survival（OS）(Wild Type KRAS) | 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. | The primary end point was 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. The OS indicated above as secondary outcome was analyzed by wild type KRAS. |
| Secondary | Overall Survival（OS）(Mutant Type KRAS) | 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. | The primary end point was 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. The OS indicated above as secondary outcome was analyzed by mutant type KRAS. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival（OS） | 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. | The intent-to-treat (ITT) population: the ITT population was comprised of all patients who were randomized to study medication. | Months | MEDIAN |
| SECONDARY | 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. | The intent-to-treat (ITT) population: the ITT population was comprised of all patients who were randomized to study medication. | Months | MEDIAN |
| SECONDARY | 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. | The intent-to-treat (ITT) population: the ITT population was comprised of all patients who were randomized to study medication. | months | MEDIAN |
| SECONDARY | 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. | The tumor response evaluable (TR) population: the TR population included all patients in the ITT population who had measurable disease (at least 1 target lesion) at baseline and with at least 1 tumor evaluation while on treatment. | percentage of participants | NUMBER |
| SECONDARY | 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. | The tumor response evaluable (TR) population: the TR population included all patients in the ITT population who had measurable disease (at least 1 target lesion) at baseline and with at least 1 tumor evaluation while on treatment. | percentage of participants | NUMBER |
| SECONDARY | 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. | The tumor response evaluable (TR) population: the TR population included all patients in the ITT population who had measurable disease (at least 1 target lesion) at baseline and with at least 1 tumor evaluation while on treatment. | Months | MEDIAN |
| SECONDARY | Safety and Tolerability Evaluation Will Focus on Adverse Events and Laboratory Assessments（Adverse Events） | From the time a patient signed informed until 30 day safety follow-up visit or until initiation of new anticancer treatment, or assessed up to 30 months. | The as-treated (AT) population: the AT population contained all patients in the ITT population who received at least 1 dose of study medication and patients were analyzed according to treatment actually received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Safety and Tolerability Evaluation Will Focus on Adverse Events and Laboratory Assessments（Laboratory Assessments） | From the time a patient signed informed until 30 day safety follow-up visit or until initiation of new anticancer treatment, or assessed up to 30 months. | The as-treated (AT) population: the AT population contained all patients in the ITT population who received at least 1 dose of study medication and patients were analyzed according to treatment actually received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival（OS）(Wild Type KRAS) | 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. | The intent-to-treat (ITT) population: the ITT population was comprised of all patients who were randomized to study medication. | months | MEDIAN |
| SECONDARY | Overall Survival（OS）(Mutant Type KRAS) | 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. | The intent-to-treat (ITT) population: the ITT population was comprised of all patients who were randomized to study medication. | months | MEDIAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group120
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival（OS） | TAS-102（Trifluridine/Tipiracil） | 7.8 | 95% Confidence Interval 7.1 to 8.8 | Months | |
| Overall Survival（OS） | Placebo | 7.1 | 95% Confidence Interval 5.9 to 8.2 | Months | |
| Progression-free Survival (PFS) | TAS-102（Trifluridine/Tipiracil） | 2.0 | 95% Confidence Interval 1.9 to 2.8 | Months | |
| Progression-free Survival (PFS) | Placebo | 1.8 | 95% Confidence Interval 1.7 to 1.8 | Months | |
| Time to Treatment Failure (TTF) | TAS-102（Trifluridine/Tipiracil） | 1.9 | 95% Confidence Interval 1.9 to 2.2 | months | |
| Time to Treatment Failure (TTF) | Placebo | 1.8 | 95% Confidence Interval 1.7 to 1.8 | months | |
| Overall Response Rate (ORR; Complete Response [CR] or Partial Response [PR] Using RECIST Criteria) | TAS-102（Trifluridine/Tipiracil） | 1.1 | 95% Confidence Interval 0.2 to 3.3 | percentage of participants | |
| Overall Response Rate (ORR; Complete Response [CR] or Partial Response [PR] Using RECIST Criteria) | Placebo | 0.0 | 95% Confidence Interval 0.0 to 2.8 | percentage of participants | |
| Disease Control Rate (DCR; CR, PR, or Stable Disease) | TAS-102（Trifluridine/Tipiracil） | 44.1 | 95% Confidence Interval 37.9 to 50.3 | percentage of participants | |
| Disease Control Rate (DCR; CR, PR, or Stable Disease) | Placebo | 14.6 | 95% Confidence Interval 9.0 to 21.9 | percentage of participants |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TAS-102（Trifluridine/Tipiracil） | 271 | |
| Overall Study | STARTED | Placebo | 135 | |
| Overall Study | COMPLETED | TAS-102（Trifluridine/Tipiracil） | 271 | |
| Overall Study | COMPLETED | Placebo | 135 | |
| Overall Study | NOT COMPLETED | TAS-102（Trifluridine/Tipiracil） | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events194
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | TAS-102 | 124 | 271 | 151 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 27 | 135 | 28 |
| other | Neutropenia | Blood and lymphatic system disorders | TAS-102 | 98 | 271 | 214 |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo | 2 | 135 | 2 |
| other | Leukopenia | Blood and lymphatic system disorders | TAS-102 | 47 | 271 | 94 |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo | 1 | 135 | 1 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | TAS-102 | 23 | 271 | 46 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo | 4 | 135 | 5 |
| other | Nausea | Gastrointestinal disorders | TAS-102 | 104 | 271 | 164 |
| other | Nausea | Gastrointestinal disorders | Placebo | 20 | 135 | 25 |
1 to 10 of 194Source ClinicalTrials.gov
See all 194 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TAS-102 | 205 | 271 |
| Total, all-cause mortality | Placebo | 111 | 135 |
| Total, other adverse events | TAS-102 | 269 | 271 |
| Total, other adverse events | Placebo | 120 | 135 |
| Total, serious adverse events | TAS-102 | 63 | 271 |
| Total, serious adverse events | Placebo | 32 | 135 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29215955 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| TAS-102 vs Placebo: deaths from any cause | Trial comparisons |
| TAS-102 vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01955837
GET https://conductscience.org/api/trials/v1/NCT01955837/results?page=2