Stereotactic ablative radiotherapy for the comprehensive treatment of 4-10 oligometastatic tumors (SABR-COMET-10): study protocol for a randomized phase III trial.

ABSTRACT:

Background

Stereotactic ablative radiotherapy (SABR) has emerged as a new treatment option for patients with oligometastatic disease. SABR delivers precise, high-dose, hypofractionated radiotherapy, and achieves excellent rates of local control for primary tumors or metastases. A recent randomized phase II trial evaluated SABR in a group of patients with a small burden of oligometastatic disease (mostly with 1-3 metastatic lesions), and found that SABR was associated with benefits in progression-free survival and overall survival. The goal of this phase III trial is to assess the impact of SABR in patients with 4-10 metastatic cancer lesions.

Methods

One hundred and fifty-nine patients will be randomized in a 1:2 ratio between the control arm (consisting of standard of care

SUBMITTER: Palma DA 

PROVIDER: S-EPMC6699121 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature