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

Tracking Information

First Received Date ^ICMJE

April 6, 2012

Last Updated Date

June 27, 2012

Start Date ^ICMJE

August 2012

Estimated Primary Completion Date

August 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01574729 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Phase II Study of Surgery Combined With Recombinant Adenoviral Human p53 Gene Therapy in Treatment Advanced Non-small-cell Carcinoma

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Non-small Cell Lung Cancer

Intervention ^ICMJE

Drug: Surgery combined with rAd-p53 gene therapy
Surgery combined with rAd-p53 gene therapy during surgery plus post-surgery chemotherapy
Procedure: Surgery
Surgery plus post-surgery chemotherapy

Study Arm (s)

Active Comparator: Surgery plus post-surgery chemotherapy
Surgery plus post-surgery chemotherapy

Intervention: Procedure: Surgery
Experimental: Surgery combined with rAd-p53 gene therapy
Surgery combined with the surgery wound surface injection of rAd-p53 plus post-surgery chemotherapy

Intervention: Drug: Surgery combined with rAd-p53 gene therapy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

120

Estimated Completion Date

October 2015

Estimated Primary Completion Date

August 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Qunyou Tan, M.D., Ph.D

13983770929

13983770929@163.com

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01574729

Other Study ID Numbers ^ICMJE

rAd-p53NSCLC

Has Data Monitoring Committee

Responsible Party

Shenzhen SiBiono GeneTech Co.,Ltd

Study Sponsor ^ICMJE

Shenzhen SiBiono GeneTech Co.,Ltd

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Qunyou Tan, M.D., Ph.D

Institute of Surgery Research, Daping Hospital, Third Military Medical University

Information Provided By

Shenzhen SiBiono GeneTech Co.,Ltd

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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