Spots Global Cancer Trial Database for Regorafenib in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction Who Have Completed Chemoradiation Therapy and Surgery
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Regorafenib in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction Who Have Completed Chemoradiation Therapy and Surgery
Official Title: Randomized Phase II Double Blind Study of Adjuvant Regorafenib vs Placebo in Patients With Node Positive Esophageal Cancer That Completed Pre-operative Therapy
Study ID: NCT02234180
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
Name: Yelena Janjigian
Affiliation: Academic and Community Cancer Research United
Role: PRINCIPAL_INVESTIGATOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
