NRG-BR001
Terminated
Protocol Information
A Phase 1 Study of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Multiple Metastases
Principal Investigator
Steven Chmura
Status
Terminated
Open to Accrual
June 30, 2014
Open to Accrual
August 4, 2014
Temporarily Closed to Accrual
August 4, 2014
Temporarily Closed to Accrual
September 23, 2014
Open to Accrual
September 23, 2014
Open to Accrual
October 6, 2014
Closed to Accrual
March 20, 2018
Closed to Accrual & Treatment
March 20, 2018
Complete
April 22, 2021
Terminated
May 20, 2022
Disease Site
Breast [BR] Breast
Phase
I
Developmental Therapeutics
No
Primary Objective
To determine the recommended SBRT dose for each of the metastatic locations being treated given the individual and overlapping fields when multiple metastases are treated with SBRT in a national clinical trials network setting.
Patient Population
Oligometastases arising from the breast, lung or prostate; oligometastases defined as ≤ 4 distinct metastases visualized on standard imaging studies; all metastases not resected must be amenable to SBRT; local and regional disease treated per standard of care with no evidence of progression.
Target Accrual
84
Protocol Documents
Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website.
- BR001-Study-Memorandum-mediastinal-cervical-lymph-node-closure-August-17-2017.pdf
- NRG-BR001-Closure-March-20-2018.pdf
- NRG-BR001-Study-Memorandum-Amendment-3-December-28-2015.pdf
- NRG-BR001-Study-Memorandum-March-17-2017.pdf
- NRG-BR001-Study-Memorandum-June-27-2017.pdf
- NRG-BR001-Study-Memorandum-August-11-2016.pdf
- NRG-BR001-Study-Memorandum-October-13-2016.pdf