Oligometastatic Malignant Solid Neoplasm Clinical Trial
Official title:
External Beam Radiation to Eliminate Nominal Metastatic Disease (EXTEND): A Randomized Phase II Basket Trial Assessing the Efficacy of Upfront Local Consolidative Therapy (LCT) for Oligometastatic Disease
This phase II trial studies how well systemic therapy with or without local consolidative therapy work in treating patients with solid tumor that has spread to 1 site of other places in the body. Treatment with up-front local consolidative therapy may be better in helping to control the disease.
PRIMARY OBJECTIVES: I. In patients with oligometastatic malignancies, to assess progression free survival (PFS) with upfront local consolidative therapy (LCT) versus (vs.) no LCT among randomized patients. SECONDARY OBJECTIVES: I. In patients with oligometastatic malignancies, to assess overall survival (OS) with upfront LCT vs. no LCT among randomized patients. II. In patients with oligometastatic malignancies, to assess time to next line systemic therapy with upfront LCT vs. no LCT. III. In patients with oligometastatic malignancies, to assess time to new lesion failure with upfront LCT vs. no LCT. IV. To assess safety/tolerability of upfront LCT in patients with oligometastatic malignancies. V. In patients with oligometastatic malignancies, to assess quality of life with upfront LCT vs. no LCT. EXPLORATORY OBJECTIVES: I. To identify predictive/prognostic biomarkers that are associated with a benefit to LCT across disease sites. II. To investigate the systemic immune activating effects of radiation. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive up-front standard of care LCT including but not limited to surgical resection, cryotherapy, and radiofrequency ablation. Patients then receive routine drug therapy. ARM II: Patients receive routine drug therapy. Patients may later receive LCT at the discretion of doctor. After completion of study, patients are followed up every 18 weeks. ;