TRACE: Tirapazamine-Radiation And Cisplatin Evaluation

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Collaborator: Groupe Oncologie Radiotherapie Tete et Cou
• Treatments: Cisplatin; Tirapazamine

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