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

July 13, 2015 updated by: Tianjin Medical University Cancer Institute and Hospital

Clinical Study of Recombinant Human Endostatin Combined With NP Chemotherapy in the Treatment of Stage ⅢA Non Small Cell Lung Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Tianjin Medical University Cancer Institute and Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor Regression Rate
Time Frame: 3 months
Target lesion size reduction ratio
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease free survival is defined as the time from randomization to disease recurrence or death which comes first.
Time Frame: 5 years
5 years
Overall Survival
Time Frame: 5 years
the time from randomization to death.
5 years
Clinical Benefit Rate
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

July 5, 2015

First Submitted That Met QC Criteria

July 13, 2015

First Posted (Estimate)

July 14, 2015

Study Record Updates

Last Update Posted (Estimate)

July 14, 2015

Last Update Submitted That Met QC Criteria

July 13, 2015

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMUCIH-ENDU-S001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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