Completed

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

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What is being tested

Endostar

+ Vinorelbine

+ Cisplatin

DrugRadiation
Who is being recruted

Bronchial Neoplasms+7

+ Carcinoma, Bronchogenic

+ Lung Diseases

Over 18 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: December 2008
See protocol details

Summary

Principal SponsorFudan University
Last updated: September 19, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2008

Actual date on which the first participant was enrolled.

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.

NCT01687439
Principal SponsorFudan University
Last updated: September 19, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

15 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsCarcinoma, Non-Small-Cell Lung

Criteria

8 inclusion criteria required to participate
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
ECOG PS 0-1
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10 exclusion criteria prevent from participating
Allergic to any of the study drugs
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
Evidence of bleeding diathesis or coagulopathy
Gastrointestinal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months before enrollment
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Fudan University Shanghai Cancer Center

Shanghai, ChinaOpen Fudan University Shanghai Cancer Center in Google Maps
CompletedOne Study Center