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

Sponsor
Fudan University
Study ID
NCT01687439
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Endostar — DRUG
    7.5mg/m2, D1-14
  • Vinorelbine — DRUG
    25-30mg/m2, D1,8
  • Cisplatin — DRUG
    25 mg/m2, D1-3
  • Radiotherapy — RADIATION

Study Details

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.

Key Dates

Start date
Dec 31, 2008
Status verified
Sep 2012
Primary completion
Oct 31, 2009
Completion
Oct 31, 2009

Study Design

Enrollment
15 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Tumor blood volume [ Time Frame: 3 months ]

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