Concomitant Radiation and Cisplatin With and Without Tirapazamine in Treatment of Advanced Head and Neck Cancer
- Conditions
- Head and Neck Neoplasms
- Registration Number
- NCT00094081
- Lead Sponsor
- Sanofi
- Brief Summary
The trial will compare the efficacy and safety of concomitant chemoradiation with tirapazamine, cisplatin and radiation versus cisplatin and radiation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 861
- Previously untreated squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx.
- Stage III or IV disease (excluding T1N1, and T2N1).
- ECOG performance status less than or equal to 2.
- Absolute neutrophil count at least 1.5 X 10^9/L, platelet count at least 100 X 10^9/L, and hemoglobin > 9g/dL.
- Serum bilirubin < 1.25 times ULN and AST/ALT < 2.5 times ULN.
- Calculated creatinine clearance (Cockcroft-Gault) > 55 mL/min.
- Metastatic Disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Overall survival.
- Secondary Outcome Measures
Name Time Method Time to locoregional failure.
Trial Locations
- Locations (10)
Foundation for Cancer Research and Education
🇺🇸Phoenix, Arizona, United States
Stanford University Medical Center
🇺🇸Palo Alto, California, United States
H-Lee Moffitt Cancer Center and Research
🇺🇸Tampa, Florida, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Harper Hospital
🇺🇸Detroit, Michigan, United States
VA New Jersey Health Care Medical Center
🇺🇸East Orange, New Jersey, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Eastern Virginia Medical School
🇺🇸Norfolk, Virginia, United States
Foundation for Cancer Research and Education🇺🇸Phoenix, Arizona, United States