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

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2018
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.
Epistemonikos ID: d07b553c2d2941ccc5beaeec1988e7a525e3bb15
First added on: May 21, 2024