Trial Information
Randomized, Open-label, phase3 Trial Comparing Amrubicin Combined With Cisplatin Versus Etoposide-Cisplatin as First-line Treatment in Patients With Extensive Disease SCLC
Inclusion Criteria:
- Histologically/cytologically proven small cell lung cancer
- Extensive disease
- No prior chemotherapy regimen
- Age 18 years or older
- ECOG performance status of 0-1
Exclusion Criteria:
- Brain metastasis requiring treatment
- Treatment (Surgical or radiotherapy)of primary tumor
- Interstitial pneumonia or pulmonary fibrosis
- Abnormal cardiac function or myocardial infraction within 6 months before study
enrollment
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall survival
Outcome Time Frame:
1.5 years after last subject first visit
Safety Issue:
No
Principal Investigator
Yan Sun, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Cancer hospital, Chinese Academy of Medical Science
Authority:
China: Food and Drug Administration
Study ID:
D0750018
NCT ID:
NCT00660504
Start Date:
April 2008
Completion Date:
March 2012
Related Keywords:
- Lung Cancer
- Extensive Disease-Small Cell Lung Cancer
- Lung Neoplasms
- Small Cell Lung Carcinoma