TRACE: Tirapazamine-Radiation And Cisplatin Evaluation (TRACE)
Head and Neck Squamous Cell Carcinoma
About this trial
This is an interventional treatment trial for Head and Neck Squamous Cell Carcinoma focused on measuring Tirapazamine, Head and Neck Cancer, Cisplatin, Radiation
Eligibility Criteria
Inclusion Criteria: Previously untreated squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx. Stage III or IV disease (excluding T1N1, and T2N1 and metastatic disease). Eastern Cooperative Oncology Group (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 upper limit of normal (ULN) and aspartate aminotransferase (AST)/alanine transaminase (ALT) < 2.5 times ULN. Calculated creatinine clearance (Cockcroft-Gault) > 55 mL/min. Exclusion Criteria: Metastatic Disease Primary cancers of the nasal and paranasal cavities and of the nasopharynx Significant intercurrent illness that will interfere with the Chemotherapy or Radiation Therapy during the trial Symptomatic peripheral neuropathy > grade 2 Clinically significant hearing impairment Significant cardiac disease
Sites / Locations
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- sanofi-aventis New Zealand administrative office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Tirapazamine + Cisplatin
Cisplatin