Status:
COMPLETED
TRACE: Tirapazamine-Radiation And Cisplatin Evaluation
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Groupe Oncologie Radiotherapie Tete et Cou
Conditions:
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The trial will compare the efficacy and safety of concomitant chemoradiation with tirapazamine, cisplatin and radiation versus cisplatin and radiation.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
317 Patients enrolled
Trial Details
Trial ID
NCT00174837
Start Date
April 1 2005
End Date
January 1 2008
Last Update
May 26 2016
Active Locations (17)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
3
Sanofi-Aventis Administrative Office
Cove, Australia
4
Sanofi-Aventis Administrative Office
Laval, Canada