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.
PRIMARY OBJECTIVES: I. To compare the disease-free survival (DFS) for patients with resected esophageal and gastroesophageal (GE) junction adenocarcinoma treated with regorafenib vs. placebo in the adjuvant setting. SECONDARY OBJECTIVES: I. To compare the safety profile of adjuvant regorafenib vs. placebo in patients with locally advanced resectable esophageal and GE junction adenocarcinoma. II. To compare the overall survival (OS) for patients with resected esophageal and GE junction adenocarcinoma treated with regorafenib vs. placebo in the adjuvant setting. III. To compare the DFS in those patients that receive at least 1 cycle of therapy. IV. To collect tumor samples for future genomic analysis to explore the biology of locally advanced esophageal and GE junction adenocarcinoma. V. DFS will be compared between the arms from the time of surgery as well. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Within 6-12 weeks after surgery, patients receive regorafenib orally (PO) once daily (QD) on days 1-21. ARM II: Within 6-12 weeks after surgery, patients receive placebo PO QD on days 1-21. In both arms, courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years, and every 6 months for up to 5 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
3
Given PO
Given PO
Carle Cancer Center
Urbana, Illinois, United States
Cancer Center of Kansas - Wichita
Wichita, Kansas, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States
Mayo Clinic
Rochester, Minnesota, United States
Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, United States
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 frame: Time from randomization to the first of either disease recurrence or death from any cause, assessed up to 1 year and 10 months
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.
Time frame: Up to 1 year and 10 months
Overall Survival (OS)
Overall survival (OS) is defined as the time from randomization to death due to any cause.
Time frame: Time from randomization to death due to any cause, assessed up to 1 year and 10 months
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