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Surgery Combined With rAd-p53 Gene in Treatment Advanced Non-small-cell Carcinoma

This study is not yet open for participant recruitment.
Verified June 2012 by Shenzhen SiBiono GeneTech Co.,Ltd
Sponsor:
Information provided by (Responsible Party):
Shenzhen SiBiono GeneTech Co.,Ltd
ClinicalTrials.gov Identifier:
NCT01574729
First received: April 6, 2012
Last updated: June 27, 2012
Last verified: June 2012
History of Changes
  Purpose

The primary objectives of this study are to investigate the efficacy and safety of surgery combined with rAd-p53 gene therapy in treatment of advanced Non-small-cell lung carcinoma (NSCLC). The study efficacy endpoints include overall survival, progress-free survival, quality of life, and local recurrent rate. The safety endpoint is complications and adverse effects.

The study hypothesis: rAd-p53 gene therapy can prolong the overall survival and reduce the local recurrent rate.


Condition Intervention Phase
Non-small Cell Lung Cancer
 Drug: Surgery combined with rAd-p53 gene therapy
Procedure: Surgery
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Surgery Combined With Recombinant Adenoviral Human p53 Gene Therapy in Treatment Advanced Non-small-cell Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Shenzhen SiBiono GeneTech Co.,Ltd:

Primary Outcome Measures:
  • overall survival [ Time Frame: 3 year after the treatment ] [ Designated as safety issue: No ]
    determine the 3-years overall survival

  • adverse effects [ Time Frame: from starting treatment to 30 days after treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • local recurrent rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: August 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Surgery plus post-surgery chemotherapy
Surgery plus post-surgery chemotherapy
 Procedure: Surgery
Surgery plus post-surgery chemotherapy
Experimental: Surgery combined with rAd-p53 gene therapy
Surgery combined with the surgery wound surface injection of rAd-p53 plus post-surgery chemotherapy
 Drug: Surgery combined with rAd-p53 gene therapy
Surgery combined with rAd-p53 gene therapy during surgery plus post-surgery chemotherapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • historically diagnosed advanced non-small lung cancer
  • has surgery indication
  • age 18 years old or greater
  • life expectancy greater than 12 weeks
  • ECOG: 0-2
  • no prior chemotherapy, radiotherapy in 2 weeks
  • Neutrophils≥1.5×10^9/L,platelet≥80×10^9/L, Hb≥≥80g/L,bilirubin≤1.5×2mg/dl, ALT and AST≤2×institutional upper limit of normal,Cr≤1.5×institutional upper limit of normal,coagulation tests(INR and PTT)within normal range
  • subject provides signed informed consent

Exclusion Criteria:

  • hypersensitive to study drug
  • with a coagulational test unnormal or a bleeding disorder
  • infections
  • with serious condition which can't stand a surgery
  • pregnant or lactating
  • principle investigator consider not suitable
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01574729

Contacts
Contact: Qunyou Tan, M.D., Ph.D 13983770929 13983770929@163.com

Locations
China, Chongqing
Institute of Surgery Research, Daping Hospital, Third Military Medical University Not yet recruiting
Chongqing, Chongqing, China, 40042
Contact: Qunyou Tang, M.D., Ph.D     13983770929     13983770929@163.com    
Principal Investigator: qunyou tan, M.D., Ph.D            
Sponsors and Collaborators
Shenzhen SiBiono GeneTech Co.,Ltd
Investigators
Principal Investigator: Qunyou Tan, M.D., Ph.D Institute of Surgery Research, Daping Hospital, Third Military Medical University
  More Information

No publications provided

Responsible Party: Shenzhen SiBiono GeneTech Co.,Ltd
ClinicalTrials.gov Identifier: NCT01574729     History of Changes
Other Study ID Numbers: rAd-p53NSCLC
Study First Received: April 6, 2012
Last Updated: June 27, 2012
Health Authority: China: Military Health Department

Keywords provided by Shenzhen SiBiono GeneTech Co.,Ltd:
p53 gene therapy
non-small cell lung cancer
post-surgery
chemotherapy

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Li-Fraumeni Syndrome
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
 Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on June 13, 2013