Phase III, multicenter, randomized trial of 45 Gy versus 30 Gy thoracic radiation for extensive-stage small cell lung cancer (ES-SCLC): Study protocol.

Abstract

Consolidative thoracic radiotherapy (cTRT) has previously shown benefit to patients with extensive stage small cell lung cancer (ES-SCLC) who respond to chemotherapy. However, the optimum dose of cTRT is unknown. The purpose of this randomized trial is to compare the efficacy of 45 Gy in 15 fractions with 30 Gy in 10 fractions cTRT in ES-SCLC. This phase III, multicenter, randomized trial is designed to evaluate the safety and efficacy of different cTRT dose in ES-SCLC. Eligible patients with pathologically confirmed ES-SCLC who responded to 4-6 cycles of etoposide plus cisplatin (EP) or carboplatin (EC) chemotherapy were randomized 1:1 to receive either 30 Gy in 10 fractions (standard dose) or 45 Gy in 15 fractions (high dose) cTRT. The primary endpoint is 2-year overall survival (OS). Secondary endpoints include 2-year progression-free survival (PFS), 2-year local control (LC) and treatment related toxicity as measured by adverse events according to the Common Terminology Criteria for Adverse Events (version 4.0). The present study is the first randomized phase III trial designed to evaluate the efficacy of higher versus lower dose cTRT in ES-SCLC, providing evidence for future clinical practice in prolonging survival of patients with ES-SCLC.