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Effect of Endostar Combined With Chemotherapy and Radiotherapy on Blood Vessels and Microenvironment of Tumor for Non-small Cell Lung Cancer (NSCLC)

This study has been completed.
Information provided by (Responsible Party):
Fan Ming, Fudan University Identifier:
First received: August 16, 2012
Last updated: September 18, 2012
Last verified: September 2012

Primary objective: functional imaging and quantitative imaging detection of the effects of Endostar combined with chemotherapy and radiotherapy on Non-small Cell Lung Cancer (NSCLC).

Secondary objective: To evaluate 1) the role of Endostar in regulating tumor vessels and normalizing of microenvironment; 2) Toxicity of Endostar combined with chemotherapy.

Condition Intervention Phase
Non-small Cell Lung Cancer Drug: Endostar Drug: Vinorelbine Drug: Cisplatin Radiation: Radiotherapy Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Endostar Combined With Chemotherapy and Radiotherapy on Blood Vessels and Microenvironment of Tumor for Non-small Cell Lung Cancer

Resource links provided by NLM:

Further study details as provided by Fan Ming, Fudan University:

Primary Outcome Measures:
  • Tumor blood volume [ Time Frame: 3 months ]
  • Tumor blood flow [ Time Frame: 3 months ]
  • Permeability-surface area product [ Time Frame: 3 months ]
  • 18-FDG PET SUV values [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • The incidence of adverse events [ Time Frame: 3 months ]

Enrollment: 15
Study Start Date: December 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Eligible patients receive one cycle of Endostar monotherapy, two cycles of Endostar combined with chemotherapy (vinorelbine plus cisplatin) treatment, followed by Endostar plus radiotherapy treatment.
Drug: Endostar
7.5mg/m2, D1-14
Drug: Vinorelbine
25-30mg/m2, D1,8
Drug: Cisplatin
25 mg/m2, D1-3
Radiation: Radiotherapy


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically or cytologically proven inoperable stage IIIb-IV NSCLC
  • ECOG PS 0-1
  • Life expectancy > 3 months
  • Adequate blood functions: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L, and hemoglobin ≥ 9 g / dL
  • Adequate liver function: total bilirubin <1.5 times the upper limit of normal (ULN); AST and ALT <2.5 times ULN in patients without liver metastases, <5 times ULN in patients with liver metastases
  • Adequate renal function: serum creatinine ≤ 1.25 times ULN or calculated creatinine clearance ≥ 50 mL / min and urinary protein <2+. In patients with baseline urinary protein ≥ 2+, 24 hours urine should be collected and 24 hours urine protein ≤ 1g
  • International normalized ratio (INR) ≤ 1.5 and prothrombin time(PT) ≤ 1.5 times ULN within 7 days before enrollment
  • Written informed consent

Exclusion Criteria:

  • Evidence of bleeding diathesis or coagulopathy
  • History of hemoptysis, defined as bright red blood more than half a teaspoon 3 months before enrollment
  • Previously received chemotherapy and radiotherapy and biological targeted therapy
  • Uncontrolled hypertension (systolic blood pressure> 150 mmHg and/or diastolic blood pressure> 100 mm Hg)
  • Clinically significant (ie, active) cardiovascular diseases, such as cerebrovascular accident (within 6 months before initiating treatment), myocardial infarction (within 6 months before initiating treatment), unstable angina, congestive heart failure (New York Heart Association class ≥Grade II) , serious arrhythmia which needs medication during the study and may affect the study or can not be controlled by drugs
  • Unhealed wounds, active peptic ulcer or fracture
  • Gastrointestinal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months before enrollment
  • Women with intact uterus (menopause more than two years excluded) who are unwilling to take effective non-hormonal contraception (IUD, spermicide barrier birth control device or sterilization) during the study. Male who are unwilling to take effective contraceptive measures during the study
  • Participated in other clinical trials within 28 days before the initiation of treatment.
  • Allergic to any of the study drugs
  Contacts and Locations
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Please refer to this study by its identifier: NCT01687439

Fudan University Shanghai Cancer Center
Shanghai, China
Sponsors and Collaborators
Fudan University
Principal Investigator: Guoliang Jiang, MD Fudan University
Principal Investigator: Ming Fan, MD Fudan University
  More Information

Responsible Party: Fan Ming, Associate Professor, Fudan University Identifier: NCT01687439     History of Changes
Other Study ID Numbers: NSCLC0901
Study First Received: August 16, 2012
Last Updated: September 18, 2012

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Antineoplastic Agents, Phytogenic processed this record on August 18, 2017