Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
317 participants
INTERVENTIONAL
2005-04-30
2008-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tirapazamine + Cisplatin
Tirapazamine
in combination with cisplatin and concomitant radiation
Cisplatin
with concomitant radiation
Cisplatin
Cisplatin
with concomitant radiation
Interventions
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Tirapazamine
in combination with cisplatin and concomitant radiation
Cisplatin
with concomitant radiation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Groupe Oncologie Radiotherapie Tete et Cou
OTHER
Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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ICD CSD
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Sanofi-Aventis Administrative Office
Buenos Aires, , Argentina
Sanofi-Aventis Administrative Office
Cove, , Australia
Sanofi-Aventis Administrative Office
Laval, , Canada
Sanofi-Aventis Administrative Office
Santiago, , Chile
Sanofi-Aventis Administrative Office
Paris, , France
Sanofi-Aventis Administrative Office
Berlin, , Germany
Sanofi-Aventis Administrative Office
Causeway Bay, , Hong Kong
Sanofi-Aventis Administrative Office
Budapest, , Hungary
Sanofi-Aventis Administrative Office
Milan, , Italy
sanofi-aventis New Zealand administrative office
Macquarie Park, , New Zealand
Sanofi-Aventis Administrative Office
Warsaw, , Poland
Sanofi-Aventis Administrative Office
Singapore, , Singapore
Sanofi-Aventis Administrative Office
Midrand, , South Africa
Sanofi-Aventis Administrative Office
Barcelona, , Spain
Sanofi-Aventis Administrative Office
Geneva, , Switzerland
Sanofi-Aventis Administrative Office
Taipei, , Taiwan
Countries
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Related Links
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Related Info
Other Identifiers
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SR259075
Identifier Type: -
Identifier Source: secondary_id
EFC5512
Identifier Type: -
Identifier Source: org_study_id
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