Phase ⅡClinical Trial of Randomized Concurrent Chemoradiotherapy or Radiotherapy Alone for Local-advanced Small Cell Lung Cancer After Induced Chemotherapy
Small cell lung cancer (SCLC) represents 15-30% of all lung malignancies in China.
Limited-stage small cell lung cancer (LS-SCLC) represents approximately 40% of cases. The
current standard of care in limited-stage disease is systemic chemotherapy plus concurrent
thoracic radiotherapy. Early concurrent chemo-radiotherapy is recommended for patients with
limited-stage SCLC based on randomized trials. But, the administration of thoracic
radiotherapy requires the assessment of several factors, including the volume of the
radiation port, dose of radiation, and fractionation of radiotherapy. Parts of the LS-SCLC
are local advanced stage (stage Ⅲa and Ⅲb), which can not tolerate concurrent
chemo-radiotherapy because of large size in tumor and extensive metastasis of lymph nodes.
At present, it is usually use 3-4 cycles of introduction chemotherapy to decrease the tumor
size followed by definitive radiotherapy. But it is unclear whether this scheme is tolerant
well or it could improve the overall survival in patients with LS-SCLC. As a result, we
designed a prospective phase II randomized controlled trial in order to compare the
tolerance and therapeutic effects between radiotherapy alone and concurrent
chemo-radiotherapy after 3-4 cycles of chemotherapy in LS-SCLC.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
disease free survival
DFS was defined as the length of time from the date of randomization to the date of first documentation of relapse of SCLC or any other type of cancer or death.
QING SONG PANG, M.D
Department of Radiation Oncology, Tianjin Medical University Cancer Hospital
China: Food and Drug Administration