A Phase II Study Evaluating Stereotactic Body Radiotherapy plus Standard Therapy versus Standard Therapy Alone in Patients with Oligometastatic Breast Cancer or Lung Cancer

Full Title

PROMISE-005: A Phase II Randomized Study Assessing the Efficacy of Stereotactic Body Radiotherapy (SBRT) in Patients with Oligometastatic Breast or Lung Cancer

Purpose

Breast cancer (TNBC) and non-small cell lung cancer (NSCLC) that spread to other parts of the body (metastasize) are usually treated with chemotherapy, immunotherapy, targeted therapies, and/or radiation therapy. In this study, researchers want to see if using stereotactic body radiosurgery (SBRT) to all metastatic tumors plus standard therapy is more effective than standard therapy alone in patients with oligometastatic TNBC or NSCLC (five or fewer metastatic tumors).

SBRT is a form of radiation therapy in which high doses of radiation are given very precisely, typically over five or fewer treatments. In this study, patients will be randomly assigned to receive SBRT followed by standard therapy, or standard therapy alone.

Protocol
18-486
Phase
Phase II (phase 2)
Disease Status
Newly Diagnosed & Relapsed/Refractory
Investigator
ClinicalTrials.gov ID
NCT03808337