Surgery Combined With rAd-p53 Gene in Treatment Advanced Non-small-cell Carcinoma
rAd-p53
Phase II Study of Surgery Combined With Recombinant Adenoviral Human p53 Gene Therapy in Treatment Advanced Non-small-cell Carcinoma
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 nonsmall-cell-lung-cancer
Started Aug 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2012
CompletedFirst Posted
Study publicly available on registry
April 10, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedJune 28, 2012
June 1, 2012
3 years
April 6, 2012
June 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
overall survival
determine the 3-years overall survival
3 year after the treatment
adverse effects
from starting treatment to 30 days after treatment
Secondary Outcomes (2)
local recurrent rate
3 years
quality of life
3 years
Study Arms (2)
Surgery plus post-surgery chemotherapy
ACTIVE COMPARATORSurgery plus post-surgery chemotherapy
Surgery combined with rAd-p53 gene therapy
EXPERIMENTALSurgery combined with the surgery wound surface injection of rAd-p53 plus post-surgery chemotherapy
Interventions
Surgery combined with rAd-p53 gene therapy during surgery plus post-surgery chemotherapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Surgery Research, Daping Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 40042, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qunyou Tan, M.D., Ph.D
Institute of Surgery Research, Daping Hospital, Third Military Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2012
First Posted
April 10, 2012
Study Start
August 1, 2012
Primary Completion
August 1, 2015
Study Completion
October 1, 2015
Last Updated
June 28, 2012
Record last verified: 2012-06