Curative Effect Study of Endostatin Combined With Chemoradiotherapy to Non-small-cell Lung Cancer

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of Endostar combined with concurrent chemo-radiotherapy (CCRT) in patients with unresectable stage III non-small-cell lung cancer (NSCLC).

Detailed Description
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OBJECTIVES: Primary:To assess the treatment response rate (RR) of Endostar in combination with CCRT Secondary The progression-free survival (PFS) The overall survival(OS). The failed treatment modality. The toxicity of this regimen. OUTLINE CCRT:Patients receive chemotherapy comprising Docetaxel(65mg/m2,iv gtt duration>1h) and Cisplatin(65mg/m2,concurrent hydration) on days 1 and 29 and at least 3 hours after chemotherapy undergo concurrent 3D-CRT five days a week for total dose 60-66Gy. Endostatin:Patients receive Endostatin 7.5mg/m2 daily by iv gtt up to 7 days consecutively 1 week before radiotherapy and repeat every 2 weeks. Patients are seen in follow-up every 3 months for 2 years and then every 6 months thereafter. Physical examination and CT scans of the thorax and upper abdomen are performed routinely.

Official Title
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Phase I/II Clinical Trial of Recombinant Human Endostatin in Combination With Concurrent Chemo-Radiotherapy in the Patients With Unresectable Stage III Non-small-Cell Lung Cancer

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Endostatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age untreated pathologically confirmed inoperable stage IIIA or IIIB NSCLC weight loss of less than 10% in the past 6 months performance status (PS) of 0 to 1 forced vital capacity in 1 second (FEV1) higher than 0.8 L measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST). absolute neutrophil count (ANC) of ≥ 1500/μL hemoglobin ≥ 10 mg/dL platelet ≥ 100,000/μL serum creatinine ≤ 1.25 times of upper limit of normal (ULN) calculated creatinine clearance (CrCl) of ≥ 60 ml/min bilirubin 1.5×ULN AST and ALT less than 2.5×ULN alkaline phosphatase less than 5×ULN. Exclusion Criteria: active infection history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias) malnutrition (loss of ≥ 20% of the original body weight) sensor or motor neuropathy > grade I second primary malignancy, except for non-melanoma skin cancer psychiatric illness or social situation that would preclude study compliance pregnant or lactating women preexisting bleeding diatheses or coagulopathy Prior chemotherapy,chest irradiation therapy, or therapy directed at the epidermal growth factor receptor pathway

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endostatin combine CCRT<br>7.5mg/m2,iv gtt daily up to 7 days,beginning 1 week before radiotherapy,and repeat every 2 weeks | Drug: Endostatin<br>* 7.5mg/m2,iv gtt daily up to 7 days,beginning 1 week before radiotherapy,and repeat every 2 weeks<br>* Other names: Endostar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate (RR) | Tumor response was evaluated with thoracic CT scans when CCRT was completed, in accordance with Response Evaluation Criteria in Solid Tumors Group (RECIST). | 4 weeks after CCRT | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stage III, Unresectable, Non-small cell lung cancer