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Basic Trial Information
Summary In this randomized, double-blind, placebo-controlled, multicentre trial, 126 patients between July 5 2007 and July 30 2008 are planned to enroll in randomized into 2 groups from 10 centers: the experimental group and control group (1:1). The code-breaking time estimate is about June 2009. The leader units are Shanghai Chest Hospital Affiliated to Shanghai Jiao-Tong University and Shanghai Changzheng Hospital. Main eligibility criteria were histologically or cytologically proven stage III or IV NSCLC, with an age of 18-75 years. All eligible patients received 1 cycle (21 days) of TC chemotherapy. After chemotherapy, patients with the curative effect reaches above SD or SD were randomized to receive endostar® plus TC or TC alone for 3 cycles. Each 21-day cycle consisted of endostar® 7.5mg/m2 on days 8 to days 21, carboplatin AUC 5 on day 1, and paclitaxel 175 mg/m on day 1. Primary endpoint: time to progression (TTP). Secondary endpoint:Progress Free Survival (PFS).1 year survival rate. objective response(OR), clinical benefit rate(CBR), median survival time (MST), quality of life (QOL) and remission rate of clinical symptom. Eligibility Criteria Inclusion Criteria:
Exclusion Criteria:
Trial Lead Organizations/Sponsors Shandong Simcere Medgenn Bio-Pharmaceutical Company, Limited
Trial Sites
Link to the current ClinicalTrials.gov record. Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov. Back to Top |
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