TRACE: Tirapazamine-Radiation And Cisplatin Evaluation

Phase 3

Completed

• Conditions: Head and Neck Squamous Cell Carcinoma
• Interventions: Drug: Tirapazamine; Drug: Cisplatin

• Registration Number: NCT00174837
• Lead Sponsor: Sanofi

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-15
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2016-04
• Disposition First Submitted: 2016-04-27
• Disposition First Submitted QC: 2016-04-27
• Last Update Submitted: 2016-04-27
• Disposition First Posted: 2016-05-26
• Last Update Posted: 2016-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 317

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tirapazamine + Cisplatin	Cisplatin	-
Cisplatin	Cisplatin	-
Tirapazamine + Cisplatin	Tirapazamine	-

Primary Outcome Measures

Name	Time	Method
Overall survival	Study period

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

sanofi-aventis New Zealand administrative office; 🇳🇿 Macquarie Park, New Zealand

Sanofi-Aventis Administrative Office; 🇨🇳 Taipei, Taiwan