NRG-GI007

Open 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

Open to Accrual

Activation Date:

June 29, 2020

Most Recent Amendment Date:

January 11, 2022

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) and are not candidates for surgery, but are candidates for chemoradiation. Gastroesophageal junction tumors must be Siewert Type I/II.

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.

Support NRG Oncology.
Help Our Cause.

We are a leading protocol organizations within the National Clinical Trials Network and we seek to improve the lives of cancer patients by conducting practice-changing, multi-institutional clinical and translational research. Learn More

Donate Today

NRG Oncology Foundation, Inc, is a nonprofit, tax-exempt foundation. Donations to NRG Oncology help us conduct this important mission, and are tax-deductible to the extent permitted by law.