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


Phase 3
18 Years
N/A
Not Enrolling
Both
Head and Neck Neoplasms

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall survival.

Principal Investigator

ICD CSD

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

EFC4690

NCT ID:

NCT00094081

Start Date:

October 2002

Completion Date:

September 2006

Related Keywords:

  • Head and Neck Neoplasms
  • squamous cell carcinoma
  • oropharynx
  • oral cavity
  • larynx
  • hypopharynx
  • Neoplasms
  • Head and Neck Neoplasms

Name

Location

Stanford University Medical CenterStanford, California  94305-5408
Medical University of South CarolinaCharleston, South Carolina  29425-0721
University of Rochester Medical CenterRochester, New York  14642
Eastern Virginia Medical SchoolNorfolk, Virginia  23507
Foundation for Cancer Research and EducationPhoenix, Arizona  85013
University of Chicago Medical CenterChicago, Illinois  60637
Johns Hopkins HospitalBaltimore, Maryland  21287
H-Lee Moffitt Cancer Center and ResearchTampa, Florida  33612
Harper HospitalDetroit, Michigan  48201
VA New Jersey Health Care Medical CenterEast Orange, New Jersey  07018