Non-small Cell Lung Cancer
Conditions
Keywords
Radiotherapy, rh-endostatin, chemotherapy, NSCLC
Brief summary
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.
Interventions
RADIATIONradiotherapy combined with EP
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.
DRUGradiotherapy / EP combined with recombinant human endostatin
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.
Sponsors
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Simcere Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with pathologically or histologically confirmed and inoperable stage Ⅲ (Ⅲ A or unresectable Ⅲ B) NSCLC; 2. Patients with ages of 18\ 70 years, general condition ECOG performance scale （PS）≤ 1, weight loss \<10% during last 6 months; 3. 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.） 4. 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; 5. Patients could understand the circumstances of this study and those who have signed the informed consent form;
Exclusion criteria
1. Pregnant or lactating women; women of child-bearing age without contraception; 2. Acute infection or other serious underlying diseases; 3. Significant neurological, psychiatric history, including dementia which may influence the ability to understand and the informed consent; 4. 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; 5. Diabetes without control (blood-glucose is unstable or ≥ 8mol / L after administration); 6. Patients who are allergic to E. coli preparation; 7. Patients who are unsuitable to participate in this trial determined by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival (OS) | 3 years |
Secondary
| Measure | 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 |
Countries
China
Contacts
Primary ContactZhenzhou Yang, M.D.
Outcome results
None listed