TRACE: Tirapazamine-Radiation And Cisplatin Evaluation

Head and Neck Squamous Cell Carcinoma Clinical Trial

— TRACE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00174837
• Other study ID #: EFC5512
• Secondary ID: SR259075
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: January 15, 2009
• Start date: April 2005
• Est. completion date: January 2008

Study information

• Verified date: January 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 317
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

• 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 ULN and AST/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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Head and Neck Squamous Cell Carcinoma

Intervention

Drug:
• Tirapazamine (SR259075)
in combination with cisplatin and concomitant radiation
• cisplatin
with concomitant radiation

Locations

Country	Name	City	State
Argentina	Sanofi-Aventis Administrative Office	Buenos Aires
Australia	Sanofi-Aventis Administrative Office	Cove
Canada	Sanofi-Aventis Administrative Office	Laval
Chile	Sanofi-Aventis Administrative Office	Santiago
France	Sanofi-Aventis Administrative Office	Paris
Germany	Sanofi-Aventis Administrative Office	Berlin
Hong Kong	Sanofi-Aventis Administrative Office	Causeway Bay
Hungary	Sanofi-Aventis Administrative Office	Budapest
Italy	Sanofi-Aventis Administrative Office	Milan
New Zealand	sanofi-aventis New Zealand administrative office	Macquarie Park
Poland	Sanofi-Aventis Administrative Office	Warszawa
Singapore	Sanofi-Aventis Administrative Office	Singapore
South Africa	Sanofi-Aventis Administrative Office	Midrand
Spain	Sanofi-Aventis Administrative Office	Barcelona
Switzerland	Sanofi-Aventis Administrative Office	Geneva
Taiwan	Sanofi-Aventis Administrative Office	Taipei
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Groupe Oncologie Radiotherapie Tete et Cou

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  Chile,  France,  Germany,  Hong Kong,  Hungary,  Italy,  New Zealand,  Poland,  Singapore,  South Africa,  Spain,  Switzerland,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		Study period	No
Secondary	Failure Free Survival, Time To Loco-Regional Failure, Patterns of Failure		Study period	No
Secondary	Initial Response Rates at 2 Months After Completion of Chemoradiation Therapy, Final CR Rate at Six Months After Completion of Therapy		Study period	No
Secondary	Change in QoL From Baseline, Percent of Patients Who Are Feeding Tube Dependent 12 Months After Completion of Therapy		Study period	No
Secondary	Toxicity and Safety		Study period	Yes

External Links

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