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Completed

NCT Number: NCT01687439

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fudan University Shanghai Cancer Center

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endostar

Drug

7.5mg/m2, D1-14

Vinorelbine

Drug

25-30mg/m2, D1,8

Cisplatin

Drug

25 mg/m2, D1-3

Radiotherapy

Radiation

Primary outcomes

  1. Tumor blood volume

    Time frame: 3 months

  2. Tumor blood flow

    Time frame: 3 months

  3. Permeability-surface area product

    Time frame: 3 months

  4. 18-FDG PET SUV values

    Time frame: 3 months

Secondary outcomes

  1. The incidence of adverse events

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 19, 2012
Registry last updated
Sep 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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