Standard maintenance therapy versus local consolidative radiation therapy and standard maintenance therapy in 1-5 sites of oligometastatic non-small cell lung cancer: a study protocol of phase III randomised controlled trial.

ABSTRACT:

Introduction

Two-phase II randomised studies have shown a significant benefit of local consolidation therapy in oligometastatic non-small cell lung cancer (NSCLC). This phase III randomised controlled trial (RCT) will evaluate the efficacy of local consolidation radiation therapy (RT) in oligometastases (OM) NSCLC after completion of initial systemic therapy.

Methods and analysis

This is a single-centre phase III RCT of OM NSCLC patients. One hundred and ninety patients will undergo 1:1 randomisation to either standard maintenance therapy (control arm) or local consolidation RT and standard maintenance therapy (experimental arm). Patients will be stratified into the number of OM sites (1-2 vs 3-5), nodal metastases (N0-N1 vs N2-N3) and presence or absence of brain metastases

SUBMITTER: Tibdewal A 

PROVIDER: S-EPMC7970230 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature