Trial · NCT03828799
Safety, Tolerability and Efficacy of Regorafenib in Combination With FOLFIRINOX in Patients With Colorectal Cancer
NCT03828799, Phase 1, Phase 2, Completed, Institut du Cancer de Montpellier - Val d'Aurelle; results first posted 2025-01-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety, Tolerability and Efficacy of Regorafenib in Combination With FOLFIRINOX in Patients With Colorectal Cancer. Trials, record NCT03828799. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03828799
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Tolerability and Efficacy of Regorafenib in Combination With FOLFIRINOX in Patients With Colorectal Cancer
- NCT number
- NCT03828799
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 13 participants, actual
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- Folfirinox + regorafenib
- First posted
- 2019-02-04
- Last updated
- 2026-02-27
- Results first posted
- 2025-01-15
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Pre-specified Treatment-related Adverse Events | At the end of cycle 1 to 3 (each cycle is 14 days) | The physician determines pre-specified treatment-related toxicities and grades them by using the Common Terminology Criteria for Adverse Events (NCI-CTC Version 5). 1 - Mild: 2 - Moderate: 3 - Severe: 4 - Life-threatening: 5 - Death. Th evaluation is realized during the first three cycles. |
| Secondary | Progression-free Survival (PFS) | From baseline of patient until the first observed disease progression | Progression-free survival (PFS), defined as the time from date of inclusion to date of first observed disease progression (investigator's radiological or clinical assessment) or death due to any cause, if death occurs before progression is documented. . A central review of CT-scans is planned for patients found progression-free at 48 weeks. Patients without tumor progression or death at the time of analysis will be censored at their last date of tumor assessment. |
| Secondary | Number of Patients With Disease Control | Up to 6 months, from baseline of patient to the point where the values are the lowest (nadir). | The disease control corresponds to stable, partial and complete responses determined by RECIST criteria. Criteria recist are based on lesions measurement determined by radiologist. Calculation : the values at the baseline minus the lowest values (nadir) |
| Secondary | Number of Participants With Objective Response | Up to 6 months, from baseline of patient to the point where the values are the lowest (nadir). | The objective response corresponds to partial and complete responses determined by RECIST criteria. Criteria recist are based on lesions measurement determined by radiologist. Calculation : The values at the baseline minus the lowest values (nadir) |
| Secondary | Overall Survival (OS) | From baseline to date of patient death | |
| Secondary | The Median of Regression of Tumor Size | Up to 6 months, from baseline of patient to the point where the values are the lowest (nadir). | The percentage of regression of tumor size to its lowest value (nadir), compared with the pre-treatment tumor size (baseline), according to RECIST criteria (this is the reference method for evaluating cancer treatments based on the measurement of lesions by radiologist). |
| Secondary | Maintenance Treatment With Regorafenib Alone | Up to 16 weeks (after 12 cycles of Folfirinox-R) | Description by cycles of Regorafenib maintenance treatment after 12 cycles of Folfirinox-R |
| Secondary | Determination of Circulating Free DNA Concentration (Not Available) | Baseline, 8 weeks, 16 weeks etc. through the end of treatment | From baseline of first patient until the end of treatment |
| Secondary | Resection (R) Rates (Not Available) | Approximately at 6 months | Through the treatment |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Pre-specified Treatment-related Adverse Events | At the end of cycle 1 to 3 (each cycle is 14 days) | Evaluable population for Dose-limiting toxicity (DLT). The list of DLTs is pre-specified in the protocol. | participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) | From baseline of patient until the first observed disease progression | Intention to treat | Month | MEDIAN |
| SECONDARY | Number of Patients With Disease Control | Up to 6 months, from baseline of patient to the point where the values are the lowest (nadir). | Intention to treat | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Objective Response | Up to 6 months, from baseline of patient to the point where the values are the lowest (nadir). | Intention to treat | participants | NUMBER |
| SECONDARY | Overall Survival (OS) | From baseline to date of patient death | Intention to treat | Month | MEDIAN |
| SECONDARY | The Median of Regression of Tumor Size | Up to 6 months, from baseline of patient to the point where the values are the lowest (nadir). | Intention to treat | Percentage | MEDIAN |
| SECONDARY | Maintenance Treatment With Regorafenib Alone | Up to 16 weeks (after 12 cycles of Folfirinox-R) | Population by step and evaluable for safety | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Determination of Circulating Free DNA Concentration (Not Available) | Baseline, 8 weeks, 16 weeks etc. through the end of treatment | Blood samples were not analyzed because the number of patients per cohort was too low. Consequently, the data is not available and cannot be populated. | ||
| SECONDARY | Resection (R) Rates (Not Available) | Approximately at 6 months | Blood samples were not analyzed because the number of patients per cohort was too low. Consequently, the data is not available and cannot be populated. |
Source ClinicalTrials.gov
Results by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Pre-specified Treatment-related Adverse Events | Experimental: Irinotecan 150 mg/m² and Regorafenib 120 mg | 3 | participants | ||
| Number of Participants With Pre-specified Treatment-related Adverse Events | Experimental : Irinotecan 180 mg/m² and Regorafenib 120 mg | 5 | participants | ||
| Number of Participants With Pre-specified Treatment-related Adverse Events | Experimental : Irinotecan 180 mg/m² and Regorafenib 160 mg | 3 | participants | ||
| Progression-free Survival (PFS) | Experimental: Irinotecan 150 mg/m² (IV) and Regorafenib at 120 mg (PO) | 12.5 | Full Range 8.7 to 15.4 | Month | |
| Progression-free Survival (PFS) | Experimental: Irinotecan 180 mg/m² (IV) and Regorafenib at 120 mg (PO) | 8.2 | Full Range 3.1 to 9.1 | Month | |
| Progression-free Survival (PFS) | Experimental: Irinotecan 180 mg/m² (IV) and Regorafenib at 160 mg (PO) | 5.1 | Full Range 3.4 to 7.7 | Month | |
| Number of Patients With Disease Control | Experimental: Irinotecan 150 mg/m² (IV) and Regorafenib at 120 mg (PO) | 3 | Participants | ||
| Number of Patients With Disease Control | Experimental: Irinotecan 180 mg/m² (IV) and Regorafenib at 120 mg (PO) | 6 | Participants | ||
| Number of Patients With Disease Control | Experimental: Irinotecan 180 mg/m² (IV) and Regorafenib at 160 mg (PO) | 4 | Participants | ||
| Number of Participants With Objective Response | Experimental: Irinotecan 150 mg/m² (IV) and Regorafenib at 120 mg (PO) | 2 | participants |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Experimental: Irinotecan 150 mg/m² (IV) and Regorafenib 120 mg (PO) | 3 | |
| Overall Study | STARTED | Experimental: Irinotecan 180 mg/m² (IV) and Regorafenib 120 mg (PO) | 6 | |
| Overall Study | STARTED | Experimental: Irinotecan 180 mg/m² (IV) and Regorafenib 160 mg (PO) | 4 | |
| Overall Study | COMPLETED | Experimental: Irinotecan 150 mg/m² (IV) and Regorafenib 120 mg (PO) | 3 | |
| Overall Study | COMPLETED | Experimental: Irinotecan 180 mg/m² (IV) and Regorafenib 120 mg (PO) | 6 | |
| Overall Study | COMPLETED | Experimental: Irinotecan 180 mg/m² (IV) and Regorafenib 160 mg (PO) | 4 | |
| Overall Study | NOT COMPLETED | Experimental: Irinotecan 150 mg/m² (IV) and Regorafenib 120 mg (PO) | 0 | |
| Overall Study | NOT COMPLETED | Experimental: Irinotecan 180 mg/m² (IV) and Regorafenib 120 mg (PO) | 0 | |
| Overall Study | NOT COMPLETED | Experimental: Irinotecan 180 mg/m² (IV) and Regorafenib 160 mg (PO) | 0 |
Source ClinicalTrials.gov
Adverse events258
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 | Anemia | Blood and lymphatic system disorders | Experimental: Irinotecan 150 mg/m² (IV) and Regorafenib at 120 mg (PO) | 0 | 3 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Experimental: Irinotecan 180 mg/m² (IV) Cand Regorafenib at 120 mg (PO) | 3 | 6 | 8 |
| other | Anemia | Blood and lymphatic system disorders | Experimental: Irinotecan 180 mg/m² (IV) and Regorafenib at 160 mg (PO) | 2 | 4 | 4 |
| other | Hyperleukocytosis | Blood and lymphatic system disorders | Experimental: Irinotecan 150 mg/m² (IV) and Regorafenib at 120 mg (PO) | 0 | 3 | 0 |
| other | Hyperleukocytosis | Blood and lymphatic system disorders | Experimental: Irinotecan 180 mg/m² (IV) Cand Regorafenib at 120 mg (PO) | 1 | 6 | 1 |
| other | Hyperleukocytosis | Blood and lymphatic system disorders | Experimental: Irinotecan 180 mg/m² (IV) and Regorafenib at 160 mg (PO) | 0 | 4 | 0 |
| other | Lymphopenia | Blood and lymphatic system disorders | Experimental: Irinotecan 150 mg/m² (IV) and Regorafenib at 120 mg (PO) | 0 | 3 | 0 |
| other | Lymphopenia | Blood and lymphatic system disorders | Experimental: Irinotecan 180 mg/m² (IV) Cand Regorafenib at 120 mg (PO) | 0 | 6 | 0 |
| other | Lymphopenia | Blood and lymphatic system disorders | Experimental: Irinotecan 180 mg/m² (IV) and Regorafenib at 160 mg (PO) | 1 | 4 | 1 |
| other | Thrombopenia | Blood and lymphatic system disorders | Experimental: Irinotecan 150 mg/m² (IV) and Regorafenib at 120 mg (PO) | 1 | 3 | 2 |
1 to 10 of 258Source ClinicalTrials.gov
See all 258 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Experimental: Irinotecan 150 mg/m² (IV) and Regorafenib at 120 mg (PO) | 3 | 3 |
| Total, all-cause mortality | Experimental: Irinotecan 180 mg/m² (IV) Cand Regorafenib at 120 mg (PO) | 2 | 6 |
| Total, all-cause mortality | Experimental: Irinotecan 180 mg/m² (IV) and Regorafenib at 160 mg (PO) | 0 | 4 |
| Total, other adverse events | Experimental: Irinotecan 150 mg/m² (IV) and Regorafenib at 120 mg (PO) | 3 | 3 |
| Total, other adverse events | Experimental: Irinotecan 180 mg/m² (IV) Cand Regorafenib at 120 mg (PO) | 6 | 6 |
| Total, other adverse events | Experimental: Irinotecan 180 mg/m² (IV) and Regorafenib at 160 mg (PO) | 4 | 4 |
| Total, serious adverse events | Experimental: Irinotecan 150 mg/m² (IV) and Regorafenib at 120 mg (PO) | 0 | 3 |
| Total, serious adverse events | Experimental: Irinotecan 180 mg/m² (IV) Cand Regorafenib at 120 mg (PO) | 4 | 6 |
| Total, serious adverse events | Experimental: Irinotecan 180 mg/m² (IV) and Regorafenib at 160 mg (PO) | 0 | 4 |
Source ClinicalTrials.gov
Papers22
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 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/NCT03828799
GET https://conductscience.org/api/trials/v1/NCT03828799/results?page=2