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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02234180
Other study ID # RU021212I
Secondary ID NCI-2015-01699NC
Status Terminated
Phase Phase 2
First received
Last updated
Start date September 2014
Est. completion date June 8, 2016

Study information

Verified date October 2018
Source Academic and Community Cancer Research United
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized phase II trial studies how well regorafenib works in treating patients with cancer of the esophagus or gastroesophageal junction that has spread from where it started to nearby tissue or lymph nodes and have completed chemoradiation therapy and surgery. Regorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.


Description:

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Study Design


Related Conditions & MeSH terms

  • Adenocarcinoma
  • Adenocarcinoma of the Gastroesophageal Junction
  • Esophageal Neoplasms
  • Stage IIB Esophageal Adenocarcinoma
  • Stage IIIA Esophageal Adenocarcinoma
  • Stage IIIB Esophageal Adenocarcinoma
  • Stage IIIC Esophageal Adenocarcinoma

Intervention

Other:
Placebo
Given PO
Drug:
Regorafenib
Given PO

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Sponsors (2)

Lead Sponsor Collaborator
Academic and Community Cancer Research United National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Disease Free Survival (DFS) 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. Time from randomization to the first of either disease recurrence or death from any cause, assessed up to 1 year and 10 months
Secondary Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4) 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. Up to 1 year and 10 months
Secondary Overall Survival (OS) Overall survival (OS) is defined as the time from randomization to death due to any cause. Time from randomization to death due to any cause, assessed up to 1 year and 10 months
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