Trial · NCT03869892
Phase III Study in First-line Treatment of Patients With Metastatic Colorectal Cancer Who Are Not Candidate for Intensive Therapy.
NCT03869892, Phase 3, Active not recruiting, Institut de Recherches Internationales Servier
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase III Study in First-line Treatment of Patients With Metastatic Colorectal Cancer Who Are Not Candidate for Intensive Therapy. Trials, record NCT03869892. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03869892
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase III Study in First-line Treatment of Patients With Metastatic Colorectal Cancer Who Are Not Candidate for Intensive Therapy.
- NCT number
- NCT03869892
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 856 participants, actual
- Lead sponsor
- Institut de Recherches Internationales Servier
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- Trifluridine/tipiracil hydrochloride (S95005), Capecitabine, Bevacizumab experimental, Bevacizumab control
- First posted
- 2019-03-11
- Last updated
- 2025-12-22
- Other registries' IDs
- eudract:2017-004059-22
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | Up to 24 months | Time elapsed between the randomization and the date of radiological tumour progression (according to RECIST 1.1) or death from any cause. |
| Secondary | Overall Survival (OS) | Up to 8 years | Time elapsed between the date of randomization and the date of death due to any cause. |
| Secondary | Overall response rate (ORR) | Up to 8 years | The proportion of patients with objective evidence of complete response (CR) or partial response (PR) according to RECIST 1.1 criteria and using investigator's tumour assessment. |
| Secondary | Disease control rate (DCR) | Up to 8 years | The proportion of patients with objective evidence of CR or PR or stable disease (SD) according to RECIST 1.1 criteria and using investigator's tumour assessment. |
| Secondary | Duration of response (DoR) | Up to 8 years | The time from the first documentation of response (CR or PR) to the first documentation of objective tumour progression or death due to any cause, whichever occurs first. |
| Secondary | Time to treatment failure (TTF) | Up to 8 years | The time from randomization to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, or death. |
| Secondary | Incidence of Adverse Events (AEs) | Up to 8 years | |
| Secondary | Number of clinically significant changes to hematology, biochemistry, coagulation and urinalysis tests | Up to 8 years | |
| Secondary | Changes in ECOG performance status | Up to 8 years | |
| Secondary | Number of clinically significant changes to blood pressure, heart rate, body temperature and body weight | Up to 8 years |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 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 |
|---|---|
| 36470291 | BACKGROUND |
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/NCT03869892
GET https://conductscience.org/api/trials/v1/NCT03869892/registered