Concomitant Radiation and Cisplatin With and Without Tirapazamine in Treatment of Advanced Head and Neck Cancer
NCT ID: NCT00094081
Last Updated: 2010-02-15
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
861 participants
INTERVENTIONAL
2002-10-31
2006-09-30
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
Interventions
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tirapazamine (SR259075)
cisplatin
Radiation Therapy
Eligibility Criteria
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Inclusion Criteria
* Stage III or IV disease (excluding T1N1, and T2N1).
* 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
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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ICD CSD
Role: STUDY_DIRECTOR
Sanofi
Locations
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Foundation for Cancer Research and Education
Phoenix, Arizona, United States
Stanford University Medical Center
Palo Alto, California, United States
H-Lee Moffitt Cancer Center and Research
Tampa, Florida, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Harper Hospital
Detroit, Michigan, United States
VA New Jersey Health Care Medical Center
East Orange, New Jersey, United States
University of Rochester Medical Center
Rochester, New York, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States
Countries
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References
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Ringash J, Fisher R, Peters L, Trotti A, O'Sullivan B, Corry J, Kenny L, Nuyts S, Wratten C, Rischin D. Effect of p16 Status on the Quality-of-Life Experience During Chemoradiation for Locally Advanced Oropharyngeal Cancer: A Substudy of Randomized Trial Trans-Tasman Radiation Oncology Group (TROG) 02.02 (HeadSTART). Int J Radiat Oncol Biol Phys. 2017 Mar 15;97(4):678-686. doi: 10.1016/j.ijrobp.2016.03.017. Epub 2016 Mar 23.
Other Identifiers
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SR259075
Identifier Type: -
Identifier Source: secondary_id
EFC4690
Identifier Type: -
Identifier Source: org_study_id
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