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

NCT01211002 | Unknown Phase 4 DMC

• 1 other identifier: sim201002
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer

Keywords

Radiotherapy; rh-endostatin; chemotherapy; NSCLC

Outcome Measures

Primary Outcomes (1)

• overall survival (OS)

  3 years

Secondary Outcomes (4)

• quality of life

  2 years

• objective response rate (ORR)

  1 years

• disease control rate (DCR)

  1 year

• progression-free survival (PFS)

  2 years

Study Arms (2)

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.

Radiation: radiotherapy combined with EP

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.

Drug: radiotherapy / EP combined with recombinant human endostatin

Interventions

radiotherapy combined with EP RADIATION

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.

radiotherapy combined with EP

radiotherapy / EP combined with recombinant human endostatin DRUG

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.

adiotherapy / EP /recombinant human endostatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Simcere Pharmaceutical Co., Ltd: lead
• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: collaborator

Study Sites (1)

Daping Hospital

Chongqin, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiotherapy; Endostatins

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Angiostatic Proteins; Angiogenic Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Collagen Type XVIII; Non-Fibrillar Collagens; Collagen; Extracellular Matrix Proteins; Scleroproteins; Biological Factors

Study Officials

• zhenzhou yang, M.D.

  Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

  STUDY CHAIR

Central Study Contacts

Zhenzhou Yang, M.D.

CONTACT

yangzhenzhou@sohu.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 27, 2010
• First Posted: September 29, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2012
• Last Updated: September 29, 2010

Record last verified: 2010-09

Locations

CN (1)