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Recombinant Human Endostatin Combined With NP in Neoadjuvant Chemotherapy of Stage ⅢA NSCLC

Sponsor
Tianjin Medical University Cancer Institute and Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02497118
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
58
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study mainly to observe the anti angiogenic drugs Endostatin (Endostar) combined with vinorelbine and Cisplatin (NP) as neoadjuvant therapy in patients with non small cell lung cancer clinical efficiency and safety. Through anti angiogenesis therapy combined with neoadjuvant chemotherapy improve the treatment of neoadjuvant therapy in tumor response rate and the rate of resection, At the same time, the study before and after the anti angiogenesis therapy in patients with peripheral blood circulation endothelial cells(CECs), levels of Endothelial progenitor cells（EPC）, micro vascular density（MVD） and vascular endothelial growth factor(VEGF) expression level, to understanding the correlation between the clinical efficacy of anti angiogenesis therapy combined with chemotherapy and the change of all these markers. In order to find the reference basis for the prediction of the effect of curative effect. The changes of blood volume, blood flow and vascular permeability of the lung cancer before and after treatment with CT perfusion imaging are studied.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Study of Recombinant Human Endostatin Combined With NP Chemotherapy in the Treatment of Stage ⅢA Non Small Cell Lung Cancer
Study Start Date :
Aug 1, 2010
Actual Primary Completion Date :
Apr 1, 2015
Actual Study Completion Date :
Jun 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Endostatin plus NP

drug:Endostatins Intravenous drip， 7.5mg/m^2, d1-14 drug:vinorelbine Intravenous drip 25mg/m^2,IV, d1, d8; drug:Cisplatin，75mg/m^2 Intravenous drip,divide into d1-3 for 2 cycles

Drug: Endostatin
Endostatin,7.5mg/m^2,intravenous, d1-14;
Other Names:
  • Endostar

    • Drug: Vinorelbine
    vinorelbine,25mg/m^2,intravenous, d1, d8;

    Drug: Cisplatin
    Cisplatin，75mg/m^2 intravenous,divide into d1-3
    Active Comparator: NP neoadjuvant chemotherapy

    drug:vinorelbine Intravenous drip 25mg/m^2,IV, d1, d8; drug:Cisplatin，75mg/m^2 Intravenous drip,divide into d1-3 for 2 cycles

    Drug: Vinorelbine
    vinorelbine,25mg/m^2,intravenous, d1, d8;

    Drug: Cisplatin
    Cisplatin，75mg/m^2 intravenous,divide into d1-3

    Outcome Measures

    Primary Outcome Measures

    1. Tumor Regression Rate [3 months]

      Target lesion size reduction ratio

    Secondary Outcome Measures

    1. Disease free survival is defined as the time from randomization to disease recurrence or death which comes first. [5 years]

    2. Overall Survival [5 years]

      the time from randomization to death.

    3. Clinical Benefit Rate [3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • The pathology proved to be non small cell lung cancer (must be histologically).

    • At present, the patients with ⅢA stage (N2) were evaluated by the assistant examination;

    • The patients were evaluated by imaging, laboratory examination and other examination;

    • Without chemotherapy or anti angiogenic therapy;

    • There can be measured lesions

    • Informed consent.

    Exclusion Criteria:

    • Pregnant, lactating women, or patients with fertility but did not take contraceptive measures.

    • Severe infection.

    • Severe heart disease.Neuropsychiatric disorders, which is not easy to control.

    • Severe diabetes.

    • There is obvious bleeding tendency.

    • The 5 years history of other tumors

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tianjin Medical University Cancer Institute and Hospital Tianjin Tianjin China 300060

    Sponsors and Collaborators

    • Tianjin Medical University Cancer Institute and Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tianjin Medical University Cancer Institute and Hospital
    ClinicalTrials.gov Identifier:
    NCT02497118
    Other Study ID Numbers:
    • TMUCIH-ENDU-S001
    First Posted:
    Jul 14, 2015
    Last Update Posted:
    Jul 14, 2015
    Last Verified:
    May 1, 2014
    Keywords provided by Tianjin Medical University Cancer Institute and Hospital
    lung cancer Anti angiogenesis therapy survival
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Vinorelbine
    Endostatins

    Study Results

    No Results Posted as of Jul 14, 2015