Effect of Endostar Combined With Chemotherapy and Radiotherapy on Blood Vessels and Microenvironment of Tumor for Non-small Cell Lung Cancer (NSCLC)
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|ClinicalTrials.gov Identifier: NCT01687439|
Recruitment Status : Completed
First Posted : September 19, 2012
Last Update Posted : September 19, 2012
Primary objective: functional imaging and quantitative imaging detection of the effects of Endostar combined with chemotherapy and radiotherapy on Non-small Cell Lung Cancer (NSCLC).
Secondary objective: To evaluate 1) the role of Endostar in regulating tumor vessels and normalizing of microenvironment; 2) Toxicity of Endostar combined with chemotherapy.
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Drug: Endostar Drug: Vinorelbine Drug: Cisplatin Radiation: Radiotherapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Endostar Combined With Chemotherapy and Radiotherapy on Blood Vessels and Microenvironment of Tumor for Non-small Cell Lung Cancer|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||October 2009|
Eligible patients receive one cycle of Endostar monotherapy, two cycles of Endostar combined with chemotherapy (vinorelbine plus cisplatin) treatment, followed by Endostar plus radiotherapy treatment.
7.5mg/m2, D1-14Drug: Vinorelbine
25-30mg/m2, D1,8Drug: Cisplatin
25 mg/m2, D1-3Radiation: Radiotherapy
- Tumor blood volume [ Time Frame: 3 months ]
- Tumor blood flow [ Time Frame: 3 months ]
- Permeability-surface area product [ Time Frame: 3 months ]
- 18-FDG PET SUV values [ Time Frame: 3 months ]
- The incidence of adverse events [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01687439
|Fudan University Shanghai Cancer Center|
|Principal Investigator:||Guoliang Jiang, MD||Fudan University|
|Principal Investigator:||Ming Fan, MD||Fudan University|