NCT01211002UnknownPhase 4
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) )
Simcere Pharmaceutical Co., Ltd1 site in 1 country170 target enrollmentStarted: October 2010Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Enrollment
- 170
- Locations
- 1
- Primary Endpoint
- overall survival (OS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
radiotherapy combined with EP
Active Comparator
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.
Intervention: radiotherapy combined with EP (Radiation)
adiotherapy / EP /recombinant human endostatin
Experimental
recombinant human endostatin: The number of courses is 3 ~ 4 and each course last for 28 days.dose:15mg，d1-14, intravenous injection.
Intervention: radiotherapy / EP combined with recombinant human endostatin (Drug)
Outcomes
Primary Outcomes
overall survival (OS)
Time Frame: 3 years
Secondary Outcomes
- disease control rate (DCR)(1 year)
- quality of life(2 years)
- objective response rate (ORR)(1 years)
- progression-free survival (PFS)(2 years)
Investigators
Study Sites (1)
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