Trial · NCT02368886
Lower or Standard Dose Regorafenib in Treating Patients With Refractory Metastatic Colorectal Cancer
NCT02368886, Phase 2, Completed, Academic and Community Cancer Research United; results first posted 2019-07-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Lower or Standard Dose Regorafenib in Treating Patients With Refractory Metastatic Colorectal Cancer. Trials, record NCT02368886. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02368886
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lower or Standard Dose Regorafenib in Treating Patients With Refractory Metastatic Colorectal Cancer
- NCT number
- NCT02368886
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 123 participants, actual
- Lead sponsor
- Academic and Community Cancer Research United
- Conditions
Colon Adenocarcinoma, Rectal Adenocarcinoma, Stage III Colorectal Cancer AJCC v7, Stage IIIA Colorectal Cancer AJCC v7, Stage IIIB Colorectal Cancer AJCC v7, Stage IIIC Colorectal Cancer AJCC v7, Stage IV Colorectal Cancer AJCC v7, Stage IVA Colorectal Cancer AJCC v7, Stage IVB Colorectal Cancer AJCC v7
- Interventions
- Clobetasol Propionate, Pharmacological Study, Quality-of-Life Assessment, Regorafenib
- First posted
- 2015-02-23
- Last updated
- 2025-06-18
- Results first posted
- 2019-07-26
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Patients in Each Arm Who Complete 2 Cycles of Protocol Treatment and Initiate Cycle 3 | At 8 weeks | Fisher exact test will be used to detect a difference course 3 between arms (starting low dose \[pooled arm A1 and A2\] versus \[vs.\] standard dose \[pooled arm B1 and B2\]). The proportion of patients who complete 2 courses of protocol treatment and initiate course 3 will be computed by arm with its 95% confidence interval using exact method. |
| Secondary | Overall Survival (OS) | Time from randomization to death due to any cause, assessed up to 2 years | OS is defined as the time from randomization to death due to any cause and will be estimated with Kaplan-Meier survival curves and differences between regorafenib arms (A vs. B) tested using log-rank tests, though these analyses are not powered for formal non-inferiority assessments. |
| Secondary | Progression Free Survival (PFS) | Time from randomization to the earlier of disease progression or death due to any cause, where progressed disease (PD) is defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, assessed up to 2 years | PFS is defined as the time from randomization to the earlier of disease progression or death due to any cause, where progressed disease (PD) is defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and will be estimated with Kaplan-Meier survival curves and differences between regorafenib arms (A vs. B) tested using log-rank tests, though these analyses are not powered for formal non-inferiority assessments. |
| Secondary | Time to Progression (TTP) | Time from randomization to disease progression, where PD is defined by RECIST 1.1, assessed up to 2 years | TTP is defined as the time from randomization to disease progression, where PD is defined by RECIST 1.1 and will be estimated with Kaplan-Meier survival curves and differences between regorafenib arms (A vs. B) tested using log-rank tests, though these analyses are not powered for formal non-inferiority assessments. |
| Secondary | Cumulative (Total) Dose of Regorafenib Received by Patients in the First Two Cycles | Up to 8 weeks | Will be summarized with descriptive statistics and compared between regorafenib arms (A vs. B). |
| Secondary | Dose Intensity of Regorafenib Received by Patients in the First Two Cycles as Measured by the Percentage of Planned Dose Received | Up to 8 weeks | Dose intensity of regorafenib received by patients in the first two cycles as measured by the percentage (%) of planned dose received |
| Secondary | Proportion of Patients Overall and Within Each Arm Experiencing Grade 3 or 4 Hand and Foot Syndrome (HFS) | 2 years | Will be computed with 95% confidence intervals. |
| Secondary | Quality of Life (QOL) (According to the HFS14 Total Score) | 8 weeks | Patients will be descriptively compared between treatment arms and between HFS treatment strategies (pre-emptive vs. reactive) according to self-reported outcomes given on the HFS14 questionnaire. Results from the course 1 and 2 HSF14 questionnaires will also be summarized descriptively as they relate to the pre-emptive versus reactive palmar-plantar erythrodysesthesia syndrome (PPES) strategies. Total HFS-14 score was calculated by summing the scores of all items and adjusting to 100 by applying a rule of three. Total scores have a range of 2-100, with the higher the score, the greater the QoL impairment. |
| Secondary | Changes in QOL (According to the Linear Analogue Self-Assessment [LASA] Questionnaire) | Baseline to 8 weeks | Changes in QOL (according to the LASA questionnaire as measured by the overall QOL question) from baseline will be compared between the treatment arms using the Kruskal-Wallis test. |
| Other | Pharmacokinetics (PK) Parameters of Regorafenib Using Liquid Chromatography Mass Spectrometry | Baseline, prior to treatment, days 7, 14, and 21 prior to treatment (course 1), and days 1 and 21 prior to treatment (course 2) | After quantitation, the average trough concentration, calculated from all available data, will be calculated. This average trough concentration will be correlated with toxicity and efficacy endpoints. Further descriptive characteristics of the pharmacokinetics will also be calculated, an example includes (but is not limited to) within-patient variability in the trough concentrations pharmacokinetic parameters will also be calculated, both overall and within courses, as a ratio of the maximum:minimum value. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Patients in Each Arm Who Complete 2 Cycles of Protocol Treatment and Initiate Cycle 3 | At 8 weeks | The data for the pre-emptive and reactive treatment with clobatasol were pooled for the comparison of the two dosing strategies (regorafenib dose escalation group (Arms A1 + A2) versus regorafenib standard dose group (Arms B1 + B2)). | proportion of patients | NUMBER |
| SECONDARY | Overall Survival (OS) | Time from randomization to death due to any cause, assessed up to 2 years | The data for the pre-emptive and reactive treatment with clobatasol were pooled for the comparison of the two dosing strategies (regorafenib dose escalation group (Arms A1 + A2) versus regorafenib standard dose group (Arms B1 + B2)). | months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) | Time from randomization to the earlier of disease progression or death due to any cause, where progressed disease (PD) is defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, assessed up to 2 years | months | MEDIAN | |
| SECONDARY | Time to Progression (TTP) | Time from randomization to disease progression, where PD is defined by RECIST 1.1, assessed up to 2 years | The data for the pre-emptive and reactive treatment with clobatasol were pooled for the comparison of the two dosing strategies (regorafenib dose escalation group (Arms A1 + A2) versus regorafenib standard dose group (Arms B1 + B2)). | months | MEDIAN |
| SECONDARY | Cumulative (Total) Dose of Regorafenib Received by Patients in the First Two Cycles | Up to 8 weeks | The data for the pre-emptive \& reactive treatment with clobatasol were pooled for the comparison of the two dosing strategies ((Arms A1 + A2) versus (Arms B1 + B2)). There are patients off-protocol treatment during cycle 1; therefore, we do not have cycle 2 dosing information for those patients who are off-protocol treatment during cycle 1. | mg/day | MEAN |
| SECONDARY | Dose Intensity of Regorafenib Received by Patients in the First Two Cycles as Measured by the Percentage of Planned Dose Received | Up to 8 weeks | The data for the pre-emptive \& reactive treatment with clobatasol were pooled for the comparison of the two dosing strategies ((Arms A1 + A2) versus (Arms B1 + B2)). | percentage of planned dose received | MEDIAN |
| SECONDARY | Proportion of Patients Overall and Within Each Arm Experiencing Grade 3 or 4 Hand and Foot Syndrome (HFS) | 2 years | proportion of participants | NUMBER | |
| SECONDARY | Quality of Life (QOL) (According to the HFS14 Total Score) | 8 weeks | Only patients that completed a post-baseline HFS14 assessment were included in analysis. | score on a scale | MEAN |
| SECONDARY | Changes in QOL (According to the Linear Analogue Self-Assessment [LASA] Questionnaire) | Baseline to 8 weeks | LASA overall score change from baseline | MEAN | |
| OTHER_PRE_SPECIFIED | Pharmacokinetics (PK) Parameters of Regorafenib Using Liquid Chromatography Mass Spectrometry | Baseline, prior to treatment, days 7, 14, and 21 prior to treatment (course 1), and days 1 and 21 prior to treatment (course 2) |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Patients in Each Arm Who Complete 2 Cycles of Protocol Treatment and Initiate Cycle 3 | Regorafenib Dose Escalation Group | 0.43 | 95% Confidence Interval 0.29 to 0.56 | proportion of patients | |
| Proportion of Patients in Each Arm Who Complete 2 Cycles of Protocol Treatment and Initiate Cycle 3 | Regorafenib Standard Dose Group | 0.26 | 95% Confidence Interval 0.15 to 0.37 | proportion of patients | |
| Overall Survival (OS) | Regorafenib Dose Escalation Group | 9.8 | 95% Confidence Interval 7.5 to 11.9 | months | |
| Overall Survival (OS) | Regorafenib Standard Dose Group | 6.0 | 95% Confidence Interval 4.9 to 10.2 | months | |
| Progression Free Survival (PFS) | Regorafenib Dose Escalation Group | 2.8 | 95% Confidence Interval 2.0 to 5.0 | months | |
| Progression Free Survival (PFS) | Regorafenib Standard Dose Group | 2.0 | 95% Confidence Interval 1.8 to 2.8 | months | |
| Time to Progression (TTP) | Regorafenib Dose Escalation Group | 2.8 | 95% Confidence Interval 1.9 to 5.7 | months | |
| Time to Progression (TTP) | Regorafenib Standard Dose Group | 2.0 | 95% Confidence Interval 1.8 to 3.3 | months | |
| Cumulative (Total) Dose of Regorafenib Received by Patients in the First Two Cycles | Regorafenib Dose Escalation Group | Cycle 1 | 91.8 | Standard Deviation 33.4 | mg/day |
| Cumulative (Total) Dose of Regorafenib Received by Patients in the First Two Cycles | Regorafenib Standard Dose Group | Cycle 1 | 133.1 | Standard Deviation 34.6 | mg/day |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A1 (Regorafenib Dose Escalation + Pre-emptive Strategy) | 29 | |
| Overall Study | STARTED | Arm A2 (Regorafenib Dose Escalation + Reactive Strategy) | 27 | |
| Overall Study | STARTED | Arm B1 (Regorafenib Standard Dose + Pre-emptive Strategy) | 34 | |
| Overall Study | STARTED | Arm B2 (Regorafenib Standard Dose + Reactive Strategy) | 33 | |
| Overall Study | COMPLETED | Arm A1 (Regorafenib Dose Escalation + Pre-emptive Strategy) | 28 | |
| Overall Study | COMPLETED | Arm A2 (Regorafenib Dose Escalation + Reactive Strategy) | 26 | |
| Overall Study | COMPLETED | Arm B1 (Regorafenib Standard Dose + Pre-emptive Strategy) | 33 | |
| Overall Study | COMPLETED | Arm B2 (Regorafenib Standard Dose + Reactive Strategy) | 29 | |
| Overall Study | NOT COMPLETED | Arm A1 (Regorafenib Dose Escalation + Pre-emptive Strategy) | 1 | |
| Overall Study | NOT COMPLETED | Arm A2 (Regorafenib Dose Escalation + Reactive Strategy) | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events596
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 | Arm A1 (Regorafenib Dose Escalation + Pre-emptive Strategy) | 4 | 28 | 5 |
| other | Anemia | Blood and lymphatic system disorders | Arm A2 (Regorafenib Dose Escalation + Reactive Strategy) | 8 | 26 | 15 |
| other | Anemia | Blood and lymphatic system disorders | Arm B1 (Regorafenib Standard Dose + Pre-emptive Strategy) | 7 | 33 | 10 |
| other | Anemia | Blood and lymphatic system disorders | Arm B2 (Regorafenib Standard Dose + Reactive Strategy) | 6 | 30 | 8 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Arm A1 (Regorafenib Dose Escalation + Pre-emptive Strategy) | 0 | 28 | 0 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Arm A2 (Regorafenib Dose Escalation + Reactive Strategy) | 0 | 26 | 0 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Arm B1 (Regorafenib Standard Dose + Pre-emptive Strategy) | 0 | 33 | 0 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Arm B2 (Regorafenib Standard Dose + Reactive Strategy) | 2 | 30 | 3 |
| other | Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | Arm A1 (Regorafenib Dose Escalation + Pre-emptive Strategy) | 0 | 28 | 0 |
| other | Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | Arm A2 (Regorafenib Dose Escalation + Reactive Strategy) | 1 | 26 | 5 |
1 to 10 of 596Source ClinicalTrials.gov
See all 596 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A1 (Regorafenib Dose Escalation + Pre-emptive Strategy) | 0 | 28 |
| Total, all-cause mortality | Arm A2 (Regorafenib Dose Escalation + Reactive Strategy) | 3 | 26 |
| Total, all-cause mortality | Arm B1 (Regorafenib Standard Dose + Pre-emptive Strategy) | 3 | 33 |
| Total, all-cause mortality | Arm B2 (Regorafenib Standard Dose + Reactive Strategy) | 2 | 30 |
| Total, other adverse events | Arm A1 (Regorafenib Dose Escalation + Pre-emptive Strategy) | 28 | 28 |
| Total, other adverse events | Arm A2 (Regorafenib Dose Escalation + Reactive Strategy) | 24 | 26 |
| Total, other adverse events | Arm B1 (Regorafenib Standard Dose + Pre-emptive Strategy) | 31 | 33 |
| Total, other adverse events | Arm B2 (Regorafenib Standard Dose + Reactive Strategy) | 30 | 30 |
| Total, serious adverse events | Arm A1 (Regorafenib Dose Escalation + Pre-emptive Strategy) | 4 | 28 |
| Total, serious adverse events | Arm A2 (Regorafenib Dose Escalation + Reactive Strategy) | 10 | 26 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA015083 | Mayo Clinic Comprehensive Cancer Center Support Grant | WILLMAN, CHERYL LYNN | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
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.
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