Systemic Therapy With or Without Local Consolidative Therapy in Treating Patients With Oligometastatic Solid Tumor

Oligometastatic Malignant Solid Neoplasm

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 PFS with upfront LCT vs. no LCT among randomized patients. In this analysis each disease site will be analyzed separately. SECONDARY OBJECTIVES: I. In patients with oligometastatic malignancies, to assess OS with upfront LCT vs. no LCT among randomized patients. In this analysis disease sites will be amalgamated and analysis will compare randomized arms. II. In patients with oligometastatic malignancies, to assess time to next line systemic therapy with upfront LCT vs. no LCT. The subsequent line of systemic therapy will be defined as the subsequent line after protocol specified systemic therapy. 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. Separate analyses will assess 1) all disease sites amalgamated and 2) all disease sites analyzed separately. VI. In patients with oligometastatic malignancies, assess time to local failure with upfront LCT vs no LCT. VII. In patients with oligometastatic prostate cancer, assess radiographic progression-free survival with upfront LCT vs no LCT. VIII. In patients with oligometastatic castrate-sensitive prostate cancer, assess castrateresistance free survival 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 alterations in biomarker profile over time and in response to radiation delivery. 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.

United States