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

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ClinicalTrials.gov Identifier: NCT01574729
Recruitment Status : Unknown
Verified June 2012 by Shenzhen SiBiono GeneTech Co.,Ltd.
Recruitment status was:  Not yet recruiting
First Posted : April 10, 2012
Last Update Posted : June 28, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Surgery combined with rAd-p53 gene therapy Procedure: Surgery Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2012
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. overall survival [ Time Frame: 3 year after the treatment ]
    determine the 3-years overall survival

  2. adverse effects [ Time Frame: from starting treatment to 30 days after treatment ]

Secondary Outcome Measures :
  1. local recurrent rate [ Time Frame: 3 years ]
  2. quality of life [ Time Frame: 3 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): 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

Responsible Party: Shenzhen SiBiono GeneTech Co.,Ltd
ClinicalTrials.gov Identifier: NCT01574729     History of Changes
Other Study ID Numbers: rAd-p53NSCLC
First Posted: April 10, 2012    Key Record Dates
Last Update Posted: June 28, 2012
Last Verified: June 2012

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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases