Clinical Randomized Study of Concurrent Chemo-radiotherapy vs Radiotherapy Alone to Local-advanced Small Cell Lung Cancer (SCLC) (SCLC)
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|ClinicalTrials.gov Identifier: NCT01745445|
Recruitment Status : Recruiting
First Posted : December 10, 2012
Last Update Posted : May 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Small Cell Lung Cancer||Other: concurrent chemo-radiotherapy arm||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase ⅡClinical Trial of Randomized Concurrent Chemoradiotherapy or Radiotherapy Alone for Local-advanced Small Cell Lung Cancer After Induced Chemotherapy|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||November 2016|
|Estimated Study Completion Date :||December 2016|
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.
- disease free survival [ Time Frame: 3 years ]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 ]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 ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|