Clinical Randomized Study of Concurrent Chemo-radiotherapy vs Radiotherapy Alone to Local-advanced Small Cell Lung Cancer (SCLC)
This trial aims to evaluate the efficacy and safety between radiotherapy alone and concurrent chemo-radiotherapy after 3-4 cycles of chemotherapy in LS-SCLC.
Small Cell Lung Cancer
Other: concurrent chemo-radiotherapy arm
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase ⅡClinical Trial of Randomized Concurrent Chemoradiotherapy or Radiotherapy Alone for Local-advanced Small Cell Lung Cancer After Induced Chemotherapy|
- disease free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]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.
- overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]OS was defined as the length of time from the date of randomization to the date of death of various reasons.
- acute and late toxic effects [ Time Frame: 3 months and 3 years ] [ Designated as safety issue: No ]acute toxic effect was defined as toxic effects less than 90 days from initiation of treatment late toxic effect was defined as toxic effects more than 90 days from initiation of treatment
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||February 2015|
|Estimated Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
Experimental: radiotherapy alone arm
VP-16 50 mg/m2 on day 1-5 and Carboplatin AUC = 5 on day 1 will be given by intravenous infusion for 3-4 cycles. Then a total dose of 60 Gy will be given in 30 fractions of 2 Gy, 5 fractions per week; All patients will be radiated by external beam radiation, using 3-D conformal radiation technique.
Other: concurrent chemo-radiotherapy arm
VP-16 50 mg/m2 on day 1-5 and Carboplatin AUC = 5 on day 1 will be given by intravenous infusion for 3-4 cycles. Then a total dose of 60 Gy will be given in 30 fractions of 2 Gy, 5 fractions per week; Starting the first cycle of concurrent chemotherapy at the first day of radiotherapy. The chemotherapeutic scheme is intravenous infusion of Cisplatin 25mg/m2 on day 1-3 and oral administration of Etoposide 100mg on day1-5 and 3 weeks as a cycle for 2 consecutive cycles.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01745445
|Contact: QING SONG PANG, M.Dfirstname.lastname@example.org|
|Department of Radiation Oncology, Tianjin Medical University Cancer Hospital||Recruiting|
|Tianjin, Tianjin, China, 300060|
|Contact: QING SONG PANG, M.D +86-22-23340123-1314 email@example.com|
|Study Director:||QING SONG PANG, M.D||Department of Radiation Oncology, Tianjin Medical University Cancer Hospital|