RTOG-1010
Terminated
Protocol Information
A Phase III Trial Evaluating the Addition of Trastuzumab to Trimodality Treatment of HER2-Overexpressing Esophageal Adenocarcinoma
Principal Investigator
Howard Safran
Status
Terminated
Open to Accrual
December 30, 2010
Closed to Accrual
November 10, 2015
Closed to Accrual & Treatment
December 21, 2016
Complete
February 1, 2022
Terminated
August 15, 2023
Disease Site
Gastrointestinal [GI] Esophageal
Phase
III
Developmental Therapeutics
No
Primary Objective
To determine if trastuzumab increases disease-free survival when combined with trimodality treatment (radiation plus chemotherapy followed by surgery) for patients with HER2-overexpressing esophageal adenocarcinoma
Patient Population
Pathologically confirmed HER2 expressing adenocarcinoma of the esophagus centrally assessed within 56 days prior to Step 2 registration; primary adenocarcinoma of the esophagus involving the mid (up to 25 cm), distal and/or esophagogastric junction.
Target Accrual
197
Protocol Documents
Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website.