NRG-GI007
Closed to Accrual & Treatment
Protocol Information
Phase I Trial with Expansion Cohort of OBP-301 (Telomelysin) and Definitive Chemoradiation for Patients with Locally Advanced Esophageal and Gastroesophageal Cancer Who Are Not Candidates for Surgery
Principal Investigator
Status
Closed to Accrual & Treatment
Open to Accrual
June 29, 2020
Temporarily Closed to Accrual
April 21, 2023
Temporarily Closed to Accrual
June 27, 2023
Open to Accrual
August 7, 2023
Closed to Accrual
July 25, 2024
Closed to Accrual & Treatment
September 6, 2024
Disease Site
Gastrointestinal [GI] Esophageal
Phase
I
Developmental Therapeutics
Yes
Primary Objective
To determine if the addition of OBP-301
to 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
21
Protocol Documents
Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website.
- NRG-GI007-Blank-Forms.pdf
- A5b-NRG-Version-Patient-History-Form-Instructions.pdf
- A5b-NRG-Version.pdf
- GI007-Certification-Form.pdf
- GI007-Certification-Instructional-Document.pdf
- NRG-GI007-Data-Submission.pdf
- NRG-GI007-Specimen-Transmittal-Form.pdf
- NRG-GI007-MSK-CPT-Specimen-Transmittal-Form.pdf
- NRG-GI007-Study-Overview_Training-Slide-Set_07302020_final.pdf
- NRG-GI007_OPEN-Eligibility-Checklist.pdf
- NRG_GI007-Initial-Activation-Study-memorandum_June-29-2020-1.pdf
- NRG-GI007-Study-Memorandum-Amendments-1-and-2-February-8-2021-1.pdf
- NRG-GI007-Study-Memorandum-Amendment-3-August-16-2021.pdf
- NRG-GI007-Study-Memorandum-Amendment-4-February-28-2022.pdf
- NRG-GI007-Study-Memorandum-Temporary-Closure_April-21-2023.pdf
- NRG-GI007-Study-Memorandum-Reopening-Protocol-Amendments-5-6_August-7-2023.pdf
- NRG-GI007-Study-Memorandum-Closure-July-25-2024.pdf