Abstract 1665TiP
Background
The optimal thoracic radiation dose for patients with extensive stage small cell lung cancer (ES-SCLC) who respond to chemotherapy remains unclear. This study aims to determine whether high-dose thoracic radiotherapy has superior efficacy compared with standard-dose thoracic radiotherapy in ES-SCLC patients.
Trial design
This multi-center, open-label, randomized, phase III trial aims to recruit patients aged 18-70 years, diagnosed cytologically or histologically as ES-SCLC without brain metastasis. All patients should have remission after 4-6 cycles of platinum-etoposide chemotherapy and prophylactic cranial irradiation of 25 Gy in 10 fractions. An estimated of 186 patients will be enrolled. Stratified by institution and number of metastases, eligible participants will be randomly assigned to receive a dose of 45 Gy in 15 fractions over 3 weeks (high-dose radiotherapy) or 30 Gy in 10 fractions over 2 weeks (standard-dose radiotherapy) in a 1:1 ratio. The primary endpoint is 2-year overall survival, and it will also be analyzed by the intention-to-treat approach. The secondary objectives include 2-year progression-free survival, 2-year local-regional control and toxicities (based on the Common Terminology Criteria for Adverse Events V.4.0). This study started in Feb 2016, and 94 patients have been accrued as of April 30, 2021.
Clinical trial identification
NCT02675088; Registered: 5 February 2016.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.