TRACE: Tirapazamine-Radiation And Cisplatin Evaluation

Sanofi

Status and phase

Completed

Phase 3

Conditions

Head and Neck Squamous Cell Carcinoma

Treatments

Drug: Cisplatin

Drug: Tirapazamine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00174837

EFC5512

SR259075

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

317 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 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