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

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) )

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 Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 170
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Chongqin, China
    • Daping Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Experimental: adiotherapy / EP /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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
overall survival (OS)	3 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Simcere Pharmaceutical Co., Ltd
• Collaborators: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Investigators: Study Chair: zhenzhou yang, M.D., Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Anticipated): December 1, 2011
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: September 27, 2010
• First Submitted That Met QC Criteria: September 28, 2010
• First Posted (Estimate): September 29, 2010

Study Record Updates

• Last Update Posted (Estimate): September 29, 2010
• Last Update Submitted That Met QC Criteria: September 28, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: chemotherapy; NSCLC; Radiotherapy; rh-endostatin
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Endostatins
• Other Study ID Numbers: sim201002