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Clinical Trials/NCT00094081
NCT00094081
Completed
Phase 3

Phase III Randomized Trial of Concomitant Radiation, Cisplatin, and Tirapazamine Versus Concomitant Radiation and Cisplatin in Patients With Advanced Head and Neck Cancer

Sanofi10 sites in 1 country861 target enrollmentOctober 2002
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ConditionsHead and Neck Neoplasms
Drugstirapazamine (SR259075)cisplatin

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Head and Neck Neoplasms
Sponsor
Sanofi
Enrollment
861
Locations
10
Primary Endpoint
Overall survival.
Status
Completed
Last Updated
16 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
October 2002
End Date
September 2006
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Sanofi

Eligibility 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).
  • •ECOG performance status less than or equal to
  • •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

Outcomes

Primary Outcomes

Overall survival.

Secondary Outcomes

  • Time to locoregional failure.

Study Sites (10)

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