TRACE: Tirapazamine-Radiation And Cisplatin Evaluation

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

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

Conditions
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Head and Neck Squamous Cell Carcinoma

Intervention / Treatment
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* Drug: Tirapazamine
* Drug: Cisplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tirapazamine + Cisplatin<br> | Drug: Tirapazamine<br>* in combination with cisplatin and concomitant radiation<br>* Other names: SR259075;Drug: Cisplatin<br>* with concomitant radiation<br>|
| Active Comparator: Cisplatin<br> | Drug: Cisplatin<br>* with concomitant radiation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | Study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure Free Survival, Time To Loco-Regional Failure, Patterns of Failure |  | 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 | 
| Change in QoL From Baseline, Percent of Patients Who Are Feeding Tube Dependent 12 Months After Completion of Therapy |  | Study period | 
| Toxicity and Safety |  | Study period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tirapazamine, Head and Neck Cancer, Cisplatin, Radiation