Trial · NCT02743221
A Study Evaluating S 95005 Plus Bevacizumab and Capecitabine Plus Bevacizumab in Patients With Previously Untreated Colorectal Cancer Who Are Non-eligible for Intensive Therapy
NCT02743221, Phase 2, Completed, Institut de Recherches Internationales Servier; results first posted 2019-04-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study Evaluating S 95005 Plus Bevacizumab and Capecitabine Plus Bevacizumab in Patients With Previously Untreated Colorectal Cancer Who Are Non-eligible for Intensive Therapy. Trials, record NCT02743221. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02743221
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Evaluating S 95005 Plus Bevacizumab and Capecitabine Plus Bevacizumab in Patients With Previously Untreated Colorectal Cancer Who Are Non-eligible for Intensive Therapy
- NCT number
- NCT02743221
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 154 participants, actual
- Lead sponsor
- Institut de Recherches Internationales Servier
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- Trifluridine/tipiracil + bevacizumab, Capecitabine + bevacizumab
- First posted
- 2016-04-19
- Last updated
- 2024-08-20
- Other registries' IDs
- eudract:2015-004544-18
- Results first posted
- 2019-04-16
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | Baseline and every 8 weeks (maximum follow-up duration: 17.9 months) | The progression free survival (PFS), defined as the time from the date of randomisation until the date of the investigator-assessed radiological disease progression or death due to any cause according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Progressive disease (PD) was defined at least a 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) and an absolute increase of at least 5 mm in the sum of lesions or the appearance of new lesions. |
| Secondary | Overall Response Rate (ORR) | Baseline and every 8 weeks (maximum follow-up duration: 17.9 months) | As per RECIST v1.1, Complete Response (CR) was disappearance of all target lesions; Partial Response (PR) was at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The ORR was the proportion of patients who presented CR or PR with confirmation at subsequent time point or at least 4 weeks later. |
| Secondary | Duration of Response (DR) | Baseline and every 8 weeks (maximum follow-up duration: 16.6 months) | The DR was calculated among patients with CR or PR as the time (months) from the first documentation of response to the first documentation of objective tumor progression or death due to any cause, whichever occurred first. |
| Secondary | Disease Control Rate (DCR) | Baseline and every 8 weeks (maximum follow-up duration: 17.9 months) | DCR was the proportion of patients with confirmed CR, PR or stable disease (SD) as best overall response. SD defined as neither sufficient decrease to qualify for PR nor sufficient increase to qualify for PD. |
| Secondary | Overall Survival (OS) | Baseline up to death or study cut-off (maximum follow-up duration: 19.9 months) | The OS was defined as the time from the date of randomisation to the date of death. If death was not confirmed, or patient was alive at study cut-off date, survival time was censored at the date of last follow-up or at the study cut-off date, whichever was earlier. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) | Baseline and every 8 weeks (maximum follow-up duration: 17.9 months) | Full Analysis Set (FAS): all randomised patients who have taken at least one dose of study treatment. | months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) | Baseline and every 8 weeks (maximum follow-up duration: 17.9 months) | FAS | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response (DR) | Baseline and every 8 weeks (maximum follow-up duration: 16.6 months) | Tumour Response population: patients with measurable disease at baseline and with at least one tumour evaluation while on treatment. | months | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) | Baseline and every 8 weeks (maximum follow-up duration: 17.9 months) | FAS | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival (OS) | Baseline up to death or study cut-off (maximum follow-up duration: 19.9 months) | FAS | months | MEDIAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) | Trifluridine/Tipiracil + Bevacizumab | 9.2 | 95% Confidence Interval 7.6 to 11.6 | months | |
| Progression Free Survival (PFS) | Capecitabine + Bevacizumab | 7.8 | 95% Confidence Interval 5.5 to 10.2 | months | |
| Overall Response Rate (ORR) | Trifluridine/Tipiracil + Bevacizumab | 26 | Participants | ||
| Overall Response Rate (ORR) | Capecitabine + Bevacizumab | 23 | Participants | ||
| Duration of Response (DR) | Trifluridine/Tipiracil + Bevacizumab | 7.9 | 80% Confidence Interval 6.01 to 14.75 | months | |
| Duration of Response (DR) | Capecitabine + Bevacizumab | 9.9 | 80% Confidence Interval 8.41 to 10.02 | months | |
| Disease Control Rate (DCR) | Trifluridine/Tipiracil + Bevacizumab | 66 | Participants | ||
| Disease Control Rate (DCR) | Capecitabine + Bevacizumab | 59 | Participants | ||
| Overall Survival (OS) | Trifluridine/Tipiracil + Bevacizumab | 18.0 | 80% Confidence Interval 15.18 to 19.48 | months | |
| Overall Survival (OS) | Capecitabine + Bevacizumab | 16.2 | 80% Confidence Interval 13.07 to 17.67 | months |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Trifluridine/Tipiracil + Bevacizumab | 77 | |
| Overall Study | STARTED | Capecitabine + Bevacizumab | 77 | |
| Overall Study | COMPLETED | Trifluridine/Tipiracil + Bevacizumab | 21 | |
| Overall Study | COMPLETED | Capecitabine + Bevacizumab | 17 | |
| Overall Study | NOT COMPLETED | Trifluridine/Tipiracil + Bevacizumab | 56 | |
| Overall Study | NOT COMPLETED | Capecitabine + Bevacizumab | 60 |
Source ClinicalTrials.gov
Adverse events776
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 | Trifluridine/Tipiracil + Bevacizumab | 22 | 77 | 31 |
| other | Anaemia | Blood and lymphatic system disorders | Capecitabine + Bevacizumab | 5 | 76 | 7 |
| other | Anaemia of chronic disease | Blood and lymphatic system disorders | Trifluridine/Tipiracil + Bevacizumab | 1 | 77 | 1 |
| other | Anaemia of chronic disease | Blood and lymphatic system disorders | Capecitabine + Bevacizumab | 1 | 76 | 1 |
| other | Anaemia of malignant disease | Blood and lymphatic system disorders | Trifluridine/Tipiracil + Bevacizumab | 5 | 77 | 5 |
| other | Anaemia of malignant disease | Blood and lymphatic system disorders | Capecitabine + Bevacizumab | 1 | 76 | 2 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Trifluridine/Tipiracil + Bevacizumab | 1 | 77 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Capecitabine + Bevacizumab | 0 | 76 | 0 |
| other | Haemolytic anaemia | Blood and lymphatic system disorders | Trifluridine/Tipiracil + Bevacizumab | 2 | 77 | 2 |
| other | Haemolytic anaemia | Blood and lymphatic system disorders | Capecitabine + Bevacizumab | 0 | 76 | 0 |
1 to 10 of 776Source ClinicalTrials.gov
See all 776 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Trifluridine/Tipiracil + Bevacizumab | 22 | 77 |
| Total, all-cause mortality | Capecitabine + Bevacizumab | 33 | 76 |
| Total, other adverse events | Trifluridine/Tipiracil + Bevacizumab | 75 | 77 |
| Total, other adverse events | Capecitabine + Bevacizumab | 69 | 76 |
| Total, serious adverse events | Trifluridine/Tipiracil + Bevacizumab | 42 | 77 |
| Total, serious adverse events | Capecitabine + Bevacizumab | 44 | 76 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Trifluridine/Tipiracil + Bevacizumab vs Capecitabine + Bevacizumab: Overall Response Rate (ORR) | Trial comparisons |
| Trifluridine/Tipiracil + Bevacizumab vs Capecitabine + Bevacizumab: Disease Control Rate (DCR) | Trial comparisons |
| Trifluridine/Tipiracil + Bevacizumab vs Capecitabine + Bevacizumab: deaths from any cause | Trial comparisons |
| Trifluridine/Tipiracil + Bevacizumab vs Capecitabine + Bevacizumab: 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/NCT02743221
GET https://conductscience.org/api/trials/v1/NCT02743221/events?page=2