TRACE: Tirapazamine-Radiation And Cisplatin Evaluation
Completed · Phase 3
Conditions studied: Head and Neck Squamous Cell Carcinoma
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
- NCT00174837
- Run by
- Sanofi
- People needed
- 317
- Starts
- 2005-04-01
- Expected to finish
- 2008-01-01
- Last updated by the study team
- 2016-05-26
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 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.
You may not qualify if…
- 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
Where it is running
- Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States
- Sanofi-Aventis Administrative Office — Buenos Aires, Argentina
- Sanofi-Aventis Administrative Office — Cove, Australia
- Sanofi-Aventis Administrative Office — Laval, Canada
- Sanofi-Aventis Administrative Office — Santiago, Chile
- Sanofi-Aventis Administrative Office — Paris, France
- Sanofi-Aventis Administrative Office — Berlin, Germany
- Sanofi-Aventis Administrative Office — Causeway Bay, Hong Kong
- Sanofi-Aventis Administrative Office — Budapest, Hungary
- Sanofi-Aventis Administrative Office — Milan, Italy
- sanofi-aventis New Zealand administrative office — Macquarie Park, New Zealand
- Sanofi-Aventis Administrative Office — Warsaw, Poland
- Sanofi-Aventis Administrative Office — Singapore, Singapore
- Sanofi-Aventis Administrative Office — Midrand, South Africa
- Sanofi-Aventis Administrative Office — Barcelona, Spain
- Sanofi-Aventis Administrative Office — Geneva, Switzerland
- Sanofi-Aventis Administrative Office — Taipei, Taiwan
Full record on ClinicalTrials.gov
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