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Concomitant Radiation and Cisplatin With and Without Tirapazamine in Treatment of Advanced Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00094081
Recruitment Status : Completed
First Posted : October 14, 2004
Last Update Posted : February 15, 2010
Information provided by:

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

Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Drug: tirapazamine (SR259075) Drug: cisplatin Procedure: Radiation Therapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 861 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2002
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

Primary Outcome Measures :
  1. Overall survival.

Secondary Outcome Measures :
  1. Time to locoregional failure.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Previously untreated squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx.
  • 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:

  • Metastatic Disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00094081

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United States, Arizona
Foundation for Cancer Research and Education
Phoenix, Arizona, United States, 85013
United States, California
Stanford University Medical Center
Palo Alto, California, United States, 94305
United States, Florida
H-Lee Moffitt Cancer Center and Research
Tampa, Florida, United States, 33612
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21231
United States, Michigan
Harper Hospital
Detroit, Michigan, United States, 48201
United States, New Jersey
VA New Jersey Health Care Medical Center
East Orange, New Jersey, United States, 07018
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14620
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Virginia
Eastern Virginia Medical School
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
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Study Director: ICD CSD Sanofi
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00094081    
Other Study ID Numbers: EFC4690
First Posted: October 14, 2004    Key Record Dates
Last Update Posted: February 15, 2010
Last Verified: February 2010
Keywords provided by Sanofi:
squamous cell carcinoma
oral cavity
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents