Trial · NCT01939223
Colorectal Cancer Treated With Adjuvant Regorafenib Versus Placebo After Curative Treatment of Liver Metastases in a Randomized, Double-blind, Placebo-Controlled Phase-III STudy
NCT01939223, Phase 3, Terminated, Bayer; results first posted 2017-10-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Colorectal Cancer Treated With Adjuvant Regorafenib Versus Placebo After Curative Treatment of Liver Metastases in a Randomized, Double-blind, Placebo-Controlled Phase-III STudy. Trials, record NCT01939223. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01939223
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Colorectal Cancer Treated With Adjuvant Regorafenib Versus Placebo After Curative Treatment of Liver Metastases in a Randomized, Double-blind, Placebo-Controlled Phase-III STudy
- NCT number
- NCT01939223
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 25 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Colorectal Neoplasms
- Interventions
- Regorafenib (Stivarga, BAY73-4506), Placebo
- First posted
- 2013-09-11
- Last updated
- 2017-10-20
- Other registries' IDs
- eudract:2012-004369-42
- Results first posted
- 2017-10-20
- Limitations and caveats
- This study was prematurely terminated. Analysis was not performed for primary and secondary outcome measures.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease Free Survival (DFS) as Assessed by the Investigator | From date of randomization to date of first observed radiographic disease recurrence (RECIST 1.1 criteria for measurable and non-measurable disease) or death due to any cause, if death occurred before disease recurrence was documented. | Disease free survival was evaluated by CT / MRI scans as assessed by the investigator, which was defined as the time (in days) from date of randomization to date of first observed radiographic disease recurrence (RECIST 1.1 criteria for measurable and non-measurable disease) or death due to any cause, if death occurred before disease recurrence was documented. For subjects without documented disease recurrence or death at the time of analysis, the DFS time was censored at the date of the last evaluable CT / MRI scan. |
| Secondary | Overall Survival (OS) | Subjects who experienced disease recurrence (either during treatment or during Active Follow-up), or otherwise withdrew from the study for any reason other than death, were followed for overall survival unless consent was withdrawn. | Overall survival (OS) is defined as the time (days) from randomization to death due to any cause. The OS time for subjects alive at the time of analysis was censored at their last date known to be alive. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Disease Free Survival (DFS) as Assessed by the Investigator | From date of randomization to date of first observed radiographic disease recurrence (RECIST 1.1 criteria for measurable and non-measurable disease) or death due to any cause, if death occurred before disease recurrence was documented. | Number of Participants Analyzed is 0 because this study was prematurely terminated and data were not collected for this endpoint. | ||
| SECONDARY | Overall Survival (OS) | Subjects who experienced disease recurrence (either during treatment or during Active Follow-up), or otherwise withdrew from the study for any reason other than death, were followed for overall survival unless consent was withdrawn. | Number of Participants Analyzed is 0 because this study was prematurely terminated and data were not collected for this endpoint. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Regorafenib 160 mg | 14 | |
| Overall Study | STARTED | Placebo | 11 | |
| Overall Study | Participants Received Treatment | Regorafenib 160 mg | 14 | |
| Overall Study | Participants Received Treatment | Placebo | 11 | |
| Overall Study | COMPLETED | Regorafenib 160 mg | 1 | |
| Overall Study | COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | Regorafenib 160 mg | 13 | |
| Overall Study | NOT COMPLETED | Placebo | 11 |
Source ClinicalTrials.gov
Adverse events206
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 | Abdominal pain | Gastrointestinal disorders | Regorafenib 160 mg (BAY73-4506) | 1 | 14 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 1 | 11 | 1 |
| other | Abscess oral | Infections and infestations | Regorafenib 160 mg (BAY73-4506) | 1 | 14 | 1 |
| other | Abscess oral | Infections and infestations | Placebo | 0 | 11 | 0 |
| other | Alanine aminotransferase increased | Investigations | Regorafenib 160 mg (BAY73-4506) | 2 | 14 | 6 |
| other | Alanine aminotransferase increased | Investigations | Placebo | 1 | 11 | 2 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Regorafenib 160 mg (BAY73-4506) | 1 | 14 | 1 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Placebo | 0 | 11 | 0 |
| other | Amylase increased | Investigations | Regorafenib 160 mg (BAY73-4506) | 2 | 14 | 4 |
| other | Amylase increased | Investigations | Placebo | 0 | 11 | 0 |
1 to 10 of 206Source ClinicalTrials.gov
See all 206 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Regorafenib 160 mg (BAY73-4506) | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Regorafenib 160 mg (BAY73-4506) | 13 | 14 |
| Total, other adverse events | Placebo | 10 | 11 |
| Total, serious adverse events | Regorafenib 160 mg (BAY73-4506) | 2 | 14 |
| Total, serious adverse events | Placebo | 0 | 11 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Regorafenib 160 mg (BAY73-4506) vs Placebo: serious adverse events |
Source 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/NCT01939223
GET https://conductscience.org/api/trials/v1/NCT01939223/events?page=2