Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd |
---|---|
Information provided by: | Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd |
ClinicalTrials.gov Identifier: | NCT00708812 |
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.
Condition | Intervention | Phase |
---|---|---|
Advanced Non-Small Cell Lung Cancer |
Drug: Endostar(Recombinant Human Endostatin Injection) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Paclitaxel Plus Carboplatin (TC) Versus TC Plus Endostar in Patients With Advanced Non-Small Cell Lung Cancer(NSCLC): Randomized, Double-Blind, Placebo-Controlled, Multicentre Study |
Estimated Enrollment: | 126 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Placebo Comparator
paclitaxel-carboplatin
|
Drug: Endostar(Recombinant Human Endostatin Injection)
Each 21-day cycle consist of endostar 7.5mg/m2 on days 8 to days 21.
|
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Han baohui, Ph.D | 86-021-6282-1990 | hbaohui@yahoo.com |
China | |
Shanghai Chest Hospital | Recruiting |
Shanghai, China, 200039 | |
Contact: Han baohui, Ph.D 86-021-6282-1990 hbaohui@yahoo.com | |
Principal Investigator: Han baohui, Ph.D |
Responsible Party: | Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd ( Jinsheng Ren ) |
Study ID Numbers: | XYL014 |
Study First Received: | June 21, 2008 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00708812 |
Health Authority: | China: Ethics Committee |
Non-small Cell Lung Cancer Endostar Paclitaxel Carboplatin |
Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Paclitaxel Lung Neoplasms Lung Diseases |
Endostatins Carboplatin Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Mitosis Modulators Antimitotic Agents Angiogenesis Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Tubulin Modulators Growth Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents, Phytogenic |