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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Head and Neck Neoplasms

Treatments: Drug: tirapazamine (SR259075); Procedure: Radiation Therapy; Drug: cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00094081

SR259075

EFC4690

Details and patient eligibility

About

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

Enrollment: 861 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• Metastatic Disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)