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

Sanofi2 sites in 2 countries317 target enrollmentApril 2005

ConditionsHead and Neck Squamous Cell Carcinoma

InterventionsTirapazamine Cisplatin

DrugsTirapazamine Cisplatin

Overview

Phase: Phase 3
Intervention: Tirapazamine
Conditions: Head and Neck Squamous Cell Carcinoma
Sponsor: Sanofi
Enrollment: 317
Locations: 2
Primary Endpoint: Overall survival
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar 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

April 2005

End Date

January 2008

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sanofi

Responsible Party

Sponsor

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 and metastatic disease).
•Eastern Cooperative Oncology Group (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 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

Arms & Interventions

Tirapazamine + Cisplatin

Intervention: Tirapazamine

Tirapazamine + Cisplatin

Intervention: Cisplatin

Cisplatin

Intervention: Cisplatin

Outcomes

Primary Outcomes

Overall survival

Time Frame: Study period

Secondary Outcomes

Toxicity and Safety(Study period)
Initial Response Rates at 2 Months After Completion of Chemoradiation Therapy, Final complete response (CR) Rate at Six Months After Completion of Therapy(Study period)
Failure Free Survival, Time To Loco-Regional Failure, Patterns of Failure(Study period)
Change in QoL From Baseline, Percent of Patients Who Are Feeding Tube Dependent 12 Months After Completion of Therapy(Study period)