NCT02234180

Regorafenib in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction Who Have Completed Chemoradiation Therapy and Surgery

Randomized Phase II Double Blind Study of Adjuvant Regorafenib vs Placebo in Patients With Node Positive Esophageal Cancer That Completed Pre-operative Therapy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Academic and Community Cancer Research United · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	Placebo	Given PO
DRUG	Regorafenib	Given PO

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-06-08
• Completion: 2016-06-08
• First posted: 2014-09-09
• Last updated: 2018-10-17
• Results posted: 2018-10-17

Locations

10 sites across 1 country: United States