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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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) )

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01211002
• Other study ID #: sim201002
• Status: Not yet recruiting
• Phase: Phase 4
• First received: September 27, 2010
• Last updated: September 28, 2010
• Start date: October 2010
• Est. completion date: December 2012

Study information

• Verified date: September 2010
• Source: Simcere Pharmaceutical Co., Ltd
• Contact: Zhenzhou Yang, M.D.
• Email: yangzhenzhou[@]sohu.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 170
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Patients with pathologically or histologically confirmed and inoperable stage ? (? A or unresectable ? 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Radiation:
• radiotherapy 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.

Drug:
• radiotherapy / 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.

Locations

Country	Name	City	State
China	Daping Hospital	Chongqin

Sponsors (2)

Lead Sponsor	Collaborator
Simcere Pharmaceutical Co., Ltd	Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival (OS)		3 years	No
Secondary	quality of life		2 years	No
Secondary	objective response rate (ORR)		1 years	No
Secondary	disease control rate (DCR)		1 year	No
Secondary	progression-free survival (PFS)		2 years	No