Spots Global Cancer Trial Database for Comparable Study of Different Thoracic Radiotherapy Regimens for Extensive Stage Small Cell Lung Cancer

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Trial Identification

Brief Title: Comparable Study of Different Thoracic Radiotherapy Regimens for Extensive Stage Small Cell Lung Cancer

Official Title: Randomized Phase III Study Comparing Different Thoracic Radiotherapy Regimens in Patients With Extensive Stage Small Cell Lung Cancer Who Respond to Chemotherapy

Study ID: NCT02675088

Conditions

Carcinoma, Small Cell

Lung Neoplasms

Interventions

high-dose TRT

standard-dose TRT

Study Description

Brief Summary: Most patients with extensive stage small-cell lung cancer (ES-SCLC) who undergo chemotherapy, and prophylactic cranial irradiation, have persistent intrathoracic disease. A Dutch study recently proved that thoracic radiotherapy(TRT), using 30 Gy in 10 fractions of 3 Gy, could improve 2-year overall survival(OS) of this patient group compared with non-TRT group. But intrathoracic progression was still high, either with or without progression elsewhere, occurring in 43.7% in the TRT group. The ideal TRT regimen for ES-SCLC is undefined. Maybe higher dose can provide better local control(LC) and overall survival. In this study, the investigators propose to give an increased dose of TRT to determine whether higher dose will improve 2-year OS, LC and progression-free survival.

Detailed Description: This is a multicenter, prospective, randomised phase III study. For patients with ES-SCLC who respond to chemotherapy after four to six cycles of standard chemotherapy (platinum etoposide), 45Gy/15F of thoracic radiotherapy will be used in experimental arm, while 30Gy/10F of thoracic radiotherapy will be used in the control arm. Both survival and toxicity of the two arms will be observed and compared.