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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
186
every day, Monday-Friday, for a total of 3 weeks, 45 Gy/ 3 Gy/ 15 f
every day, Monday-Friday, for a total of 2 weeks, 30 Gy/ 3 Gy/ 10 f
Cancer Insititute and Hosiptal of Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGZhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGoverall survival
The time interval between diagnosis and death
Time frame: 2 years
progression-free survival
The time interval between diagnosis and disease progression
Time frame: 2 years
Incidence of tumor recurrence in local or regional area
Number of patients experienceing recurrences in local or regional area divided by number of all enrolled patients
Time frame: 2 years
Incidence of radiotherapy and chemotherapy induced toxicities assessed by CTCAE v 4.0
Number of patients experienceing any toxicities induced by radiotherapy or chemotherapy divided by number of all enrolled patients
Time frame: 2 years
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