P53 Gene Combined With Radio- and Chemo-therapy in Treatment of Unresectable Locally Advanced Head and Neck Cancer
Recombinant Adenoviral Human p53 Gene Combined With Radio- and Chemo-therapy in Treatment of Unresectable, Locally Advanced Head and Neck Cancer - a Open-labeled Randomized Phase 2 Study
1 other identifier
interventional
60
1 country
1
Brief Summary
The objectives of this study are to investigate the efficacy and safety of rAd-p53 gene combined with radio- and chemo-therapy vs. radio- and chemo- therapy only in treatment of unresectable, locally advanced head and neck cancer. This is a phase 2, open labeled, and active-controlled study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2015
Typical duration for phase_2
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 20, 2015
CompletedFirst Posted
Study publicly available on registry
April 29, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedApril 29, 2015
March 1, 2015
3.6 years
April 20, 2015
April 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
progression-free survival
Patients will be followed up until progression or death, withdrawal from study, or until data cut-off after 3 years.
three years after starting treatment
Secondary Outcomes (2)
Adverse events
from starting study treatment until 30 days after the last study treatment
overall survival
three years after starting study treatment
Study Arms (2)
rAd-p53 plus radiation and chemotherapy
EXPERIMENTALrAd-p53 tumor injection combined with radio- and chemo-therapy.
radiation and chemotherapy
ACTIVE COMPARATORradiation combined with chemotherapy
Interventions
multi-point injections of rAd-p53 into tumor on day 1, 8 and 15 at a dose of 2 Ă— 10\^12 viral particles (VP) in a 21-days cycle.
radiation therapy will be given at a total dose of 60 Gy by 2.0 Gy/fraction, daily Monday-Friday for 6 weeks.
Cisplatin 100 mg/m2 IV on days 1 plus paclitaxel 30 mg/m2 IV on day 1, 8 and 15
Eligibility Criteria
You may qualify if:
- histopathologically diagnosed head and neck cancer;
- unresectable, locally advanced;
- years or older;
- with an Eastern Cooperative Oncology Group (ECOG) score of 0-2;
- with normal tests of hemogram, blood coagulation, liver and kidney function; 6.signed the informed consent form.
You may not qualify if:
- Serious blood coagulation disorder, bleeding tendency, platelet \< 6 \* 1000000000/L;
- have serious heart, lung function abnormalities or severe diabetes patients;
- active infection;
- severe atherosclerosis;
- AIDS patients;
- serious thrombotic or embolic events within 6 months;
- renal insufficiency requiring hemodialysis or peritoneal dialysis;
- pregnant or lactating women;
- mental disorder or disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jiangsu cancer hospital
Nanjing, Jiangsu, 210000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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 20, 2015
First Posted
April 29, 2015
Study Start
May 1, 2015
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
April 29, 2015
Record last verified: 2015-03