Concomitant Radiation and Cisplatin With and Without Tirapazamine in Treatment of Advanced Head and Neck Cancer

Completed · Phase 3

Conditions studied: Head and Neck Neoplasms

In brief

The trial will compare the efficacy and safety of concomitant chemoradiation with tirapazamine, cisplatin and radiation versus cisplatin and radiation.

Key facts

Study ID

NCT00094081

Run by

Sanofi

People needed

861

Starts

2002-10-01

Expected to finish

2006-09-01

Last updated by the study team

2010-02-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Metastatic Disease

Where it is running

• 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

Full record on ClinicalTrials.gov

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