NRG-GI007

Closed to Accrual

Return to Protocol Table

Phase I Trial with Expansion Cohort of OBP-301 (Telomelysin) and Definitive Chemoradiation for Patients with Locally Advanced Esophageal And Gastroesophageal Adenocarcinoma Who are Not Candidates for Surgery

Principal Investigator

Geoffrey Ku,

Status

Closed to Accrual

Date Opened To Accrual

June 29 2020

Date Closed to Accrual

July 25 2024

Disease Site

Gastrointestinal [GI]

Esophageal

Phase

Developmental Therapeutics

Yes

Primary Objective

To determine if the addition of OBP-301to chemoradiation with carboplatin/paclitaxel is safe.

Patient Population

Patients with pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma or squamous cell carcinoma (SCC) of the esophagus or gastroesophageal junction (GEJ). Gastroesophageal junction tumors must be Siewert Type I/II. Patients for whom non-operative management is a viable option in the opinion of a thoracic surgeon and/or multidisciplinary team and are candidates for chemoradiation.

Target Accrual

Protocol Documents

Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website.

Forms

Regulatory Resources

Study Memos

Other

NRG-GI007 Staff Educational Materials for OBP-301, version date March 8, 2022

NRG-GI007 Endoscopy Training - June 10, 2020

Patient Study Webpage

There is no available patient study webpage available for this trial at this time.

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