Status:
COMPLETED
Concomitant Radiation and Cisplatin With and Without Tirapazamine in Treatment of Advanced Head and Neck Cancer
Lead Sponsor:
Sanofi
Conditions:
Head and Neck Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The trial will compare the efficacy and safety of concomitant chemoradiation with tirapazamine, cisplatin and radiation versus cisplatin and radiation.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Metastatic Disease
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
861 Patients enrolled
Trial Details
Trial ID
NCT00094081
Start Date
October 1 2002
End Date
September 1 2006
Last Update
February 15 2010
Active Locations (10)
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1
Foundation for Cancer Research and Education
Phoenix, Arizona, United States, 85013
2
Stanford University Medical Center
Palo Alto, California, United States, 94305
3
H-Lee Moffitt Cancer Center and Research
Tampa, Florida, United States, 33612
4
University of Chicago Medical Center
Chicago, Illinois, United States, 60637