Trial · NCT02664077
A Study Evaluating Regorafenib Following Completion of Standard Chemotherapy for Patients With Colon Cancer
NCT02664077, Phase 3, Terminated, NSABP Foundation Inc
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study Evaluating Regorafenib Following Completion of Standard Chemotherapy for Patients With Colon Cancer. Trials, record NCT02664077. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02664077
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Evaluating Regorafenib Following Completion of Standard Chemotherapy for Patients With Colon Cancer
- NCT number
- NCT02664077
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 34 participants, actual
- Lead sponsor
- NSABP Foundation Inc
- Conditions
- Stage III (IIIB or IIIC) Colon Cancer
- Interventions
- Regorafenib, Placebo
- First posted
- 2016-01-26
- Last updated
- 2022-04-14
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease-free survival (DFS) - time from randomization until first colon cancer recurrence, second primary colon cancer, or death due to any cause. | Beginning at day 1 of cycle 3 (each cycle = 28 days) and every 6 months until study closure about 10 years | To determine whether treatment with regorafenib following adjuvant therapy improves disease-free survival (DFS) in patients with Stage IIIB or IIIC colon cancer |
| Secondary | Overall Survival (OS) - time from randomization until death from any cause. | Day 1 of every cycle of chemotherapy then 30 days post study therapy, then every 6 months (years 3-5) then yearly (years 6 & 7) | Determine the overall Survival |
| Secondary | Toxicity - frequency and severity of adverse events categorized using the NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) | Every study visit through 30 days following study therapy | Evaluate toxicity associated with study therapy |
| Secondary | Compliance - Time to discontinuation of study therapy. | Every study visit through discontinuation of study therapy, assessed for up to 24 months | Evaluate the overall tolerability and compliance with study therapy |
| Secondary | Correlative Science - Biomarker evaluations | Before randomization, prior to beginning Cycle 6, every 6 months through year 5, and at the end of study therapy (maximum of 2 years). | Explore molecular and genetic correlatives for the degree of benefit from regorafenib |
| Secondary | Correlative Science - Pharmacokinetics - Plasma regorafenib concentrations | Day 15 of Cycle 1 and Cycle 2 of study therapy. | Evaluation of exposure to regorafenib |
| Secondary | Correlative Science - Pharmacodynamics | Day 15 of Cycle 1 and Cycle 2 of study therapy. | Evaluation of relationship between plasma concentrations and/or dose, efficacy, or adverse events |
| Secondary | Compare the symptoms experienced by patients receiving regorafenib to patients receiving placebo during treatment as measured by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Baseline, 3 months, 6 months, 12 months, 18 months, 24 months and 6 months after discontinuation of protocol therapy | Severity of treatment related symptoms experienced by patients. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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 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/NCT02664077
GET https://conductscience.org/api/trials/v1/NCT02664077/registered