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

Overview

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.

Full Title of Study: “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) )”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2011

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • overall survival (OS)
    • Time Frame: 3 years

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Simcere Pharmaceutical Co., Ltd
  • Collaborator
    • Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
  • Provider of Information About this Clinical Study
    • Zhenzhou Yang M.D., Daping Hospital and Research Institute of Surgery of Third Military Medical University
  • Overall Official(s)
    • zhenzhou yang, M.D., Study Chair, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
  • Overall Contact(s)
    • Zhenzhou Yang, M.D., yangzhenzhou@sohu.com

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