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

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ClinicalTrials.gov Identifier: NCT02497118
Recruitment Status : Completed
First Posted : July 14, 2015
Last Update Posted : July 14, 2015
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital

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
Non Small Cell Lung Cancer Drug: Endostatin Drug: Vinorelbine Drug: Cisplatin Phase 4

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Study Type : Interventional  (Clinical Trial)
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 : August 2010
Actual Primary Completion Date : April 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Vinorelbine

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 Name: 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




Primary Outcome Measures :
  1. Tumor Regression Rate [ Time Frame: 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. [ Time Frame: 5 years ]
  2. Overall Survival [ Time Frame: 5 years ]
    the time from randomization to death.

  3. Clinical Benefit Rate [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02497118


Locations
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China, Tianjin
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin, China, 300060
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT02497118     History of Changes
Other Study ID Numbers: TMUCIH-ENDU-S001
First Posted: July 14, 2015    Key Record Dates
Last Update Posted: July 14, 2015
Last Verified: May 2014

Keywords provided by Tianjin Medical University Cancer Institute and Hospital:
lung cancer Anti angiogenesis therapy survival

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Cisplatin
Vinorelbine
Endostatins
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors