Trial · NCT03665506
Trifluridin/tipirACil in MeTastatIc Colorectal Cancer
NCT03665506, Completed, Servier
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trifluridin/tipirACil in MeTastatIc Colorectal Cancer. Trials, record NCT03665506. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03665506
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trifluridin/tipirACil in MeTastatIc Colorectal Cancer
- NCT number
- NCT03665506
- Status
- Completed
- Enrollment
- 315 participants, actual
- Lead sponsor
- Servier
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- Trifluridin/Tipiracil
- First posted
- 2018-09-11
- Last updated
- 2024-12-03
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall survival | Baseline up to 3 years | time from first administration of trifluridin/tipiracil to death from any cause |
| Secondary | Progression-free survival | Baseline up to 3 years | PFS: time from first administration of trifluridin/tipiracil to disease progression or death from any cause |
| Secondary | Overall response rate | Baseline up to 3 years | ORR: the proportion of patients whose best response was a complete or partial response |
| Secondary | Disease control rate 8 weeks | Baseline up to 3 years | DCR-8: the proportion of patients with a best response of complete or partial response or stable disease, with the assessment of stable disease made at least 8 weeks after first administration of trifluridin/tipiracil |
| Secondary | Trifluridin/tipiracil treatment details | Baseline | Line of Trifluridin/Tipiracil treatment (Descriptive statistics using frequency tables will be used to assess the number of prior palliative systemic antineoplastic treatment regimen) |
| Secondary | Trifluridin/tipiracil treatment details | Baseline up to 3 years | Treatment duration |
| Secondary | Trifluridin/tipiracil treatment details | Baseline up to 3 years | Dose intensity (absolute and relative) |
| Secondary | Trifluridin/tipiracil treatment details | Baseline up to 3 years | Treatment sequence (previous and subsequent therapies in relation to Trifluridin/Tipiracil treatment) (Descriptive statistics using frequency tables will be used to assess previous and subsequent palliative systemic antineoplastic treatment regimen used.) |
| Secondary | AEs and SAEs according to NCI CTCAE | Baseline up to 3 years | AEs and SAEs according to NCI CTCAE |
| Secondary | Safety laboratory values of participants | Baseline up to 3 years | By-patient display of all safety laboratory results captured as per clinical routine (e.g. CEA, CA 19-9, haemoglobin, neutrophils absolute, lymphocytes count, platelets count, leukocytes count, alkaline phosphatase, ALT (GPT), AST (GOT), bilirubin total and serum creatinine). In addition, CTCAE grades of neutrophils, white blood cell count, platelets, haemoglobin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), bilirubin, alkaline phosphatase and creatinine will be presented using frequencies and percentages for each visit. Shift tables opposing CTCAE grades during treatment to baseline CTCAE grades of the mentioned parameters will also be presented per visit using frequencies and percentages. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37260368 | 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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03665506
GET https://conductscience.org/api/trials/v1/NCT03665506/registered?page=2