Trial · NCT02234180
Regorafenib in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction Who Have Completed Chemoradiation Therapy and Surgery
NCT02234180, Phase 2, Terminated, Academic and Community Cancer Research United; results first posted 2018-10-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Regorafenib in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction Who Have Completed Chemoradiation Therapy and Surgery. Trials, record NCT02234180. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02234180
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Regorafenib in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction Who Have Completed Chemoradiation Therapy and Surgery
- NCT number
- NCT02234180
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- Academic and Community Cancer Research United
- Conditions
- Adenocarcinoma of the Gastroesophageal Junction, Stage IIB Esophageal Adenocarcinoma, Stage IIIA Esophageal Adenocarcinoma, Stage IIIB Esophageal Adenocarcinoma, Stage IIIC Esophageal Adenocarcinoma
- Interventions
- Placebo, Regorafenib
- First posted
- 2014-09-09
- Last updated
- 2018-10-17
- Results first posted
- 2018-10-17
Source ClinicalTrials.gov
Registered outcomes3
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 to the first of either disease recurrence or death from any cause, assessed up to 1 year and 10 months | Disease free survival (DFS) is defined as the time from randomization to the first of either disease recurrence or death from any cause. The distribution of DFS will be estimated using the Kaplan Meier method. |
| Secondary | Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4) | Up to 1 year and 10 months | The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns within patient groups. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either "unrelated" or "unlikely to be related" to study treatment in the event of an actual relationship developing. The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below. |
| Secondary | Overall Survival (OS) | Time from randomization to death due to any cause, assessed up to 1 year and 10 months | Overall survival (OS) is defined as the time from randomization to death due to any cause. |
Source ClinicalTrials.gov
Outcomes3
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) | Time from randomization to the first of either disease recurrence or death from any cause, assessed up to 1 year and 10 months | Only 1 patient was registered to the placebo arm. Due to protected health information, listing only 1 patient's results is contraindicated. The data below is descriptive and shouldn't be trusted because of the small sample size. | months | MEDIAN |
| SECONDARY | Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4) | Up to 1 year and 10 months | Only 1 patient was registered to the placebo arm. Due to protected health information, listing only 1 patient's results is contraindicated. The data below is descriptive and shouldn't be trusted because of the small sample size. | percentage of grade 3+ AEs | NUMBER |
| SECONDARY | Overall Survival (OS) | Time from randomization to death due to any cause, assessed up to 1 year and 10 months | Only 1 patient was registered to the placebo arm. Due to protected health information, listing only 1 patient's results is contraindicated. The data below is descriptive and shouldn't be trusted because of the small sample size. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease Free Survival (DFS) | Arm I/II (Regorafenib/Placebo) | 4.83 | 95% Confidence Interval 2.27 to 9.89 | months | |
| Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4) | Arm I/II (Regorafenib/Placebo) | 0 | percentage of grade 3+ AEs | ||
| Overall Survival (OS) | Arm I/II (Regorafenib/Placebo) | NA | 95% Confidence Interval NA to NA | months |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Regorafenib) | 2 | |
| Overall Study | STARTED | Arm II (Placebo) | 1 | |
| Overall Study | COMPLETED | Arm I (Regorafenib) | 2 | |
| Overall Study | COMPLETED | Arm II (Placebo) | 1 | |
| Overall Study | NOT COMPLETED | Arm I (Regorafenib) | 0 | |
| Overall Study | NOT COMPLETED | Arm II (Placebo) | 0 |
Source ClinicalTrials.gov
Adverse events6
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 | Diarrhea | Gastrointestinal disorders | Arm I/II (Regorafenib/Placebo) | 2 | 3 | 6 |
| other | Vomiting | Gastrointestinal disorders | Arm I/II (Regorafenib/Placebo) | 1 | 3 | 2 |
| other | Fatigue | General disorders | Arm I/II (Regorafenib/Placebo) | 1 | 3 | 3 |
| other | Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | Arm I/II (Regorafenib/Placebo) | 2 | 3 | 7 |
| other | Hypertension | Vascular disorders | Arm I/II (Regorafenib/Placebo) | 2 | 3 | 6 |
| serious | Thromboembolic event | Vascular disorders | Arm I/II (Regorafenib/Placebo) | 1 | 3 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I/II (Regorafenib/Placebo) | 0 | 3 |
| Total, other adverse events | Arm I/II (Regorafenib/Placebo) | 3 | 3 |
| Total, serious adverse events | Arm I/II (Regorafenib/Placebo) | 1 | 3 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02234180
GET https://conductscience.org/api/trials/v1/NCT02234180/registered