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Concurrent Endostar, Paclitaxel/Carboplatin and Radiotherapy for Locally Advanced Non-small Cell Lung (RT0902)
Conditions
Non-small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Conditions: Keywords
Non-small cell lung cancer, Locally advanced, Radiotherapy, Concomitant Chemotherapy, Endostar
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Endostar
Type: Drug
Name: Paclitaxel/Carboplatin
Type: Drug
Overall Status
Recruiting
Summary
Concomitant chemoradiotherapy is the standard treatment of locally advanced, non-resectable, non-small cell lung cancer (NSCLC). However, the optimal chemotherapy regimen is still controversial. The purpose of this study was to evaluate the efficacy and toxicity of a concomitant treatment using Endostar (Recombinant Human Endostatin), Paclitaxel/Carboplatin and radiotherapy for LA-NSCLC, and also assess its impact on patient Quality of Life (QoL) and progression-free survival (PFS).
Detailed Description
Patients with non-resectable non-small Cell Lung Cancer will receive thoracic radiation therapy 60-66 Gy over 30-33 fractions and concurrent with Endostar 7.5 mg/m2 over 3 hours d1-14, Paclitaxel 50 mg/m2 weekly over 1 hour, Carboplatin AUC = 2 mg/mL/min over 30 min weekly. Followed by Endostar 7.5 mg/m2 d1-14,Paclitaxel 175 mg/m2 d1 and Carboplatin AUC = 5 mg/mL/min d1 every 3 weeks for 2 cycles as consolidation treatment.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 65 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:
- Histologically proven non-small cell lung cancer (squamous cell carcinoma, adenocarcinoma, large cell carcinoma and etc)
- Presence of measurable disease by RECIST
- stage IIIA or IIIB, non-resectable
- ECOG performance status 0-1
- No prior chemotherapy, radiation therapy to chest, immunotherapy, or biologic therapy .Patients must sign an informed consent indicating that they are aware of the .investigational nature of the study in keeping with the policy of the hospital.
Exclusion Criteria:
- Carcinoid tumor, small cell carcinoma of lung
- Patients with any distant metastasis
- History of another malignancy except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
- Any other morbidity or situation with contraindication for radiotherapy (e.g. active infection, myocardial infarction preceding 6 months, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive treatment)
- Pregnant or lactating women, women who has not taken test of pregnancy (within 7 days before the first administration) and pregnant women
- Women and men of childbearing potential who have no willing of employing adequate contraception Tumor EGFR wild
- Histologically proven non-small cell lung cancer (squamous cell carcinoma, adenocarcinoma, large cell carcinoma and etc)
- Presence of measurable disease by RECIST
- stage IIIA or IIIB, non-resectable
- ECOG performance status 0-1
- No prior chemotherapy, radiation therapy to chest, immunotherapy, or biologic therapy .Patients must sign an informed consent indicating that they are aware of the .investigational nature of the study in keeping with the policy of the hospital.
Exclusion Criteria:
- Carcinoid tumor, small cell carcinoma of lung
- Patients with any distant metastasis
- History of another malignancy except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
- Any other morbidity or situation with contraindication for radiotherapy (e.g. active infection, myocardial infarction preceding 6 months, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive treatment)
- Pregnant or lactating women, women who has not taken test of pregnancy (within 7 days before the first administration) and pregnant women
- Women and men of childbearing potential who have no willing of employing adequate contraception Tumor EGFR wild
Locations
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Status: Recruiting
Contact: Shenglin Ma, MD - +8657188122568 - mashenglin@medmail.com.cn
Hangzhou, Zhejiang, China
Status: Recruiting
Contact: Xu Ya ping, MD - 0086-571-88122082 - xuyaping1207@gmail.com
Start Date
October 2009
Completion Date
December 2013
Sponsors
Zhejiang Cancer Hospital
Source
Zhejiang Cancer Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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