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

Phase 4

• Conditions: Non-small Cell Lung Cancer
• Interventions: Radiation: radiotherapy combined with EP; Drug: radiotherapy / EP combined with recombinant human endostatin

• Registration Number: NCT01211002
• Lead Sponsor: Simcere Pharmaceutical Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-09
• Study First Submitted: 2010-09-27
• Study First Submitted QC: 2010-09-28
• Last Update Submitted: 2010-09-28
• Study First Posted: 2010-09-29
• Last Update Posted: 2010-09-29
• Study Start: 2010-10
• Primary Completion: 2011-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 170

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
radiotherapy combined with EP	radiotherapy combined with EP	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.
adiotherapy / EP /recombinant human endostatin	radiotherapy / EP combined with recombinant human endostatin	recombinant human endostatin: The number of courses is 3 \~ 4 and each course last for 28 days.dose:15mg，d1-14, intravenous injection.

Primary Outcome Measures

Name	Time	Method
overall survival (OS)	3 years

Secondary Outcome Measures

Name	Time	Method
quality of life	2 years
disease control rate (DCR)	1 year
objective response rate (ORR)	1 years
progression-free survival (PFS)	2 years

Trial Locations

Locations (1)

Daping Hospital; 🇨🇳 Chongqin, China