Small Cell Lung Cancer Clinical Trial
Official title:
Etoposide-Carboplatin (EC) Versus EC Plus Endostar in Patients With Extensive Disease Small Cell Lung Cancer (ED-SCLC): Randomized, Open Label, Placebo-controlled, Multicentre Study
Background:
The effect of existing treatment modalities of extensive disease small-cell lung cancer
(ED-SCLC) is unsatisfactory. Progress of new strategies including more efficient therapy is
wanted. Endostar® (Rh-endostatin Injection) may have anti-tumor activity by against vascular
endothelial growth factor for initial treatment. This study was designed to evaluate the
safety and efficacy of Endostar® combined with etoposide-carboplatin (EC) chemotherapy in
patients with ED-SCLC seeking for more effective treatment.
Methods:
In this randomized, open label, placebo-controlled, multicentre trial, 120 patients are
planned to be enrolled at random into 2 arms(1:1) from 10 centers between June 2009 and June
2011. The leader units are Shanghai Chest Hospital Affiliated to Shanghai Jiao-Tong
University. Main eligibility criteria are histological or cytological diagnosis of ED-SCLC,
with an age of 18-75 years. All eligible patients receive etoposide-carboplatin (EC) alone
or with endostar® for 4-6 cycles (21 days for 1 cycle). In arm1 patients receive endostar®
7.5mg/m2 on day 1 to day 14, etoposide 60 mg/m2 on day 1 to day 5 and carboplatin AUC 5 on
day 1. In arm2 patients receive etoposide 60 mg/m2 on day 1 to day 5 and carboplatin AUC 5
on day 1.
Primary endpoint: progress free survival (PFS).
Secondary endpoint: progress free survival at 6 months, overall survival (OS), objective
response rate (ORR), clinical benefit rate (CBR), Response duration, time to
progression(TTP) and quality of life (QOL).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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