Trial · NCT03829462
Assessing a Regorafenib-irinotecan Combination Versus Regorafenib Alone in Metastatic Colorectal Cancer Patients
NCT03829462, Phase 3, Active not recruiting, Institut du Cancer de Montpellier - Val d'Aurelle; results first posted 2025-07-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Assessing a Regorafenib-irinotecan Combination Versus Regorafenib Alone in Metastatic Colorectal Cancer Patients. Trials, record NCT03829462. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03829462
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Assessing a Regorafenib-irinotecan Combination Versus Regorafenib Alone in Metastatic Colorectal Cancer Patients
- NCT number
- NCT03829462
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 377 participants, actual
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
- Conditions
- Metastatic Colorectal Cancer (mCRC)
- Interventions
- Regorafenib, Irinotecan
- First posted
- 2019-02-04
- Last updated
- 2025-11-21
- Results first posted
- 2025-07-18
- Limitations and caveats
* In the protocol, we had planned to randomize 78 patients, but we had also specified that endpoints could be analyzed as soon as 55 events (deaths) were reached (i.e when one of the two is reached first). When inclusion ended, we continued to record deaths and obtained 59 events for 66 randomized patients i.e 33 patients randomized in each arm.~* There is no data on race or ethnicity.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | Up to 36 months | |
| Secondary | Progression-free Survival (PFS) | Up to 36 months | |
| Secondary | Time to Deterioration | Up to 36 months | |
| Secondary | Number of Participants With Disease Control Rate | Through study completion, up to 14 months | |
| Secondary | Number of Patients With an Objective Response Rate | Through treatment completion, up to 14 months | |
| Secondary | Assessment of Adverse Events by Using the NCI-CTCAE Version 5.0 Scale (Grade Max Per Patient) | Up to 36 months | |
| Secondary | Quality of Life Questionnaire | Questionnaire is assessed until 16 weeks (baseline, 8 weeks and 16 weeks) | The Quality of Life questionnaire (QLQ-C30) is a 30-item instrument designed to measure quality of life in all cancer patients. The QLQ-C30 incorporates five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status, and a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnea, loss of appetite, insomnia and diarrhea) and perceived financial impact of the disease. Score 0 to 100 for all subscales. * Functional scale : 0 the worst outcome, 100 is the best outcome, * Symptomatic scale : 0 the best outcome, 100 is the worst outcome Global functioning measures how much a person's symptoms affect their day-to-day life and role functioning assesses a patient's ability to perform daily activities, leisure time activities, and work on a scale of 0 to 100 (0 the worst outcome and 100 the best outcome). |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | Up to 36 months | Population per-protocol | Month | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | Up to 36 months | Intention to treat | month | MEDIAN |
| SECONDARY | Time to Deterioration | Up to 36 months | Intention to treat | month | MEDIAN |
| SECONDARY | Number of Participants With Disease Control Rate | Through study completion, up to 14 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Patients With an Objective Response Rate | Through treatment completion, up to 14 months | Population Per protocol | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Assessment of Adverse Events by Using the NCI-CTCAE Version 5.0 Scale (Grade Max Per Patient) | Up to 36 months | Intention to treat | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Quality of Life Questionnaire | Questionnaire is assessed until 16 weeks (baseline, 8 weeks and 16 weeks) | The number of patients differs from the ITT population because some patients have not completed the questionnaires. Therefore the analysis is carried out on a smaller population, those who responded to the questionnaires. The table below shows the median scores of scales ranging from 0 to 100. | Units on a scale | MEDIAN |
Source ClinicalTrials.gov
Results by group104
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Irinotecan + Regorafenib (REGIRI) | 9 | 95% Confidence Interval 6.1 to 14.5 | Month | |
| Overall Survival | Regorafenib | 5.5 | 95% Confidence Interval 3.8 to 13.4 | Month | |
| Progression-free Survival (PFS) | Irinotecan + Regorafenib (REGIRI) | 3.6 | 95% Confidence Interval 2 to 4.2 | month | |
| Progression-free Survival (PFS) | Regorafenib | 1.9 | 95% Confidence Interval 1.8 to 2.1 | month | |
| Time to Deterioration | Irinotecan + Regorafenib (REGIRI) | 4.6 | 95% Confidence Interval 3.6 to 5 | month | |
| Time to Deterioration | Regorafenib | 2.1 | 95% Confidence Interval 1.4 to 3 | month | |
| Number of Participants With Disease Control Rate | Irinotecan + Regorafenib (REGIRI) | 20 | Participants | ||
| Number of Participants With Disease Control Rate | Regorafenib | 8 | Participants | ||
| Number of Patients With an Objective Response Rate | Irinotecan + Regorafenib (REGIRI) | 2 | Participants | ||
| Number of Patients With an Objective Response Rate | Regorafenib | 0 | Participants |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Irinotecan + Regorafenib (REGIRI) | 33 | |
| Overall Study | STARTED | Regorafenib | 33 | |
| Overall Study | Per Protocol Population at 8 Weeks With a Evaluation by CT Scan | Irinotecan + Regorafenib (REGIRI) | 27 | |
| Overall Study | Per Protocol Population at 8 Weeks With a Evaluation by CT Scan | Regorafenib | 29 | |
| Overall Study | COMPLETED | Irinotecan + Regorafenib (REGIRI) | 27 | |
| Overall Study | COMPLETED | Regorafenib | 29 | |
| Overall Study | NOT COMPLETED | Irinotecan + Regorafenib (REGIRI) | 6 | |
| Overall Study | NOT COMPLETED | Regorafenib | 4 |
Source ClinicalTrials.gov
Adverse events274
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 | Alopecia | Skin and subcutaneous tissue disorders | Irinotecan + Regorafenib (REGIRI) | 14 | 33 | 21 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Regorafenib | 1 | 33 | 2 |
| other | Candida infection | Infections and infestations | Irinotecan + Regorafenib (REGIRI) | 1 | 33 | 1 |
| other | Candida infection | Infections and infestations | Regorafenib | 0 | 33 | 0 |
| other | Skin rash | Skin and subcutaneous tissue disorders | Irinotecan + Regorafenib (REGIRI) | 2 | 33 | 2 |
| other | Skin rash | Skin and subcutaneous tissue disorders | Regorafenib | 1 | 33 | 1 |
| other | Erythema | Skin and subcutaneous tissue disorders | Irinotecan + Regorafenib (REGIRI) | 0 | 33 | 0 |
| other | Erythema | Skin and subcutaneous tissue disorders | Regorafenib | 1 | 33 | 1 |
| other | Erythroderma | Skin and subcutaneous tissue disorders | Irinotecan + Regorafenib (REGIRI) | 0 | 33 | 0 |
| other | Erythroderma | Skin and subcutaneous tissue disorders | Regorafenib | 1 | 33 | 1 |
1 to 10 of 274Source ClinicalTrials.gov
See all 274 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Irinotecan + Regorafenib (REGIRI) | 32 | 33 |
| Total, all-cause mortality | Regorafenib | 27 | 33 |
| Total, other adverse events | Irinotecan + Regorafenib (REGIRI) | 33 | 33 |
| Total, other adverse events | Regorafenib | 32 | 33 |
| Total, serious adverse events | Irinotecan + Regorafenib (REGIRI) | 21 | 33 |
| Total, serious adverse events | Regorafenib | 20 | 33 |
Source ClinicalTrials.gov
Papers4
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 |
|---|---|
| Irinotecan + Regorafenib (REGIRI) vs Regorafenib: Number of Patients With an Objective Response Rate | Trial comparisons |
| Irinotecan + Regorafenib (REGIRI) vs Regorafenib: Number of Participants With Disease Control Rate | Trial comparisons |
| Irinotecan + Regorafenib (REGIRI) vs Regorafenib: deaths from any cause | Trial comparisons |
| Irinotecan + Regorafenib (REGIRI) vs Regorafenib: 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/NCT03829462
GET https://conductscience.org/api/trials/v1/NCT03829462/results?page=2