Study of Concurrent Chemo-radiotherapy Combined With Recombinant Human Endostatin for Local Advanced Non-small Cell Lung Cancer (NSCLC)

Study Overview
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Brief Summary
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It is a trials to evaluate the overall survival (OS) of radiotherapy / EP combined with recombinant human endostatin in treatment of locally advanced (Ⅲ A / unresectable Ⅲ B) non-small cell lung cancer.

Official Title
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The Exploratory Clinical Study of Concurrent Chemo-radiotherapy Combined With Recombinant Human Endostatin (Endostar) for Local Advanced Non-small Cell Lung Cancer (NSCLC (Ⅲ A / Ⅲ B) )

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Radiation: radiotherapy combined with EP
* Drug: radiotherapy / EP combined with recombinant human endostatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with pathologically or histologically confirmed and inoperable stage Ⅲ (Ⅲ A or unresectable Ⅲ B) NSCLC; Patients with ages of 18 70 years, general condition ECOG performance scale （PS）≤ 1, weight loss <10% during last 6 months; CT films of patients during last 4 weeks were accessible when patients were selected into the groups, the lesions were measurable; (According to the standard of RECIST1.1, they should have at least one of accurately measurable lesions with the largest diameter ≥ 10mm by spiral CT, PET-CT, with the largest diameter≥ 20mm by ordinary CT and MRI.） No major organ dysfunction, the function of heart, liver and kidney was normal, laboratory indicators should meet the following requirements: Blood: WBC> 4.0 × 109 / L, absolute neutrophil count > 1.5 × 109 / L, platelet count> 100 × 109 / L, hemoglobin> 110g / L; liver function: serum bilirubin was less than 1.5 × maximum normal value ; ALT and AST were less than 1.5 × maximum normal value; BUN, Cr within the normal range; FEV1 > 1L or> 40% of predicted value; Patients could understand the circumstances of this study and those who have signed the informed consent form; Exclusion Criteria: Pregnant or lactating women; women of child-bearing age without contraception; Acute infection or other serious underlying diseases; Significant neurological, psychiatric history, including dementia which may influence the ability to understand and the informed consent; Receive the treatment of other experimental trials in the same period; on the medication of other anticancer drugs a the same time; have joined other drug clinical trials 30 days before this clinical trial; Diabetes without control (blood-glucose is unstable or ≥ 8mol / L after administration); Patients who are allergic to E. coli preparation; Patients who are unsuitable to participate in this trial determined by the researchers.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: radiotherapy combined with EP<br>the dose of radiotherapy is 60-66 Gy / 30-33f.The combination regimen is etoposide (50 mg/m2 day1-5, 29-33) and cisplatin (50 mg/m2 day1, 8, 29, 36) in the 1st, 4th weeks of radiotherapy for 2 courses. | Radiation: radiotherapy combined with EP<br>* Tumor vo lume is 60-66 Gy / 30-33f and the combination regimen is etoposide (50 mg/m2 day1-5, 29-33) and cisplatin (50 mg/m2 day1, 8, 29, 36) in the 1st, 4th weeks of radiotherapy for 2 courses.<br>|
| Experimental: adiotherapy / EP /recombinant human endostatin<br>recombinant human endostatin: The number of courses is 3   4 and each course last for 28 days.dose:15mg，d1-14, intravenous injection. | Drug: radiotherapy / EP combined with recombinant human endostatin<br>* Anti-vascular targeting therapy The number of courses is 3   4 and each course last for 28 days. Recombinant human endostatin（Endostar）：15mg，d1-14, intravenous injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival (OS) |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life |  | 2 years | 
| objective response rate (ORR) |  | 1 years | 
| disease control rate (DCR) |  | 1 year | 
| progression-free survival (PFS) |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiotherapy, rh-endostatin, chemotherapy, NSCLC