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Completed

NCT Number: NCT00094081

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

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

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Key information

Conditions

Head and Neck Neoplasms Carcinoma Carcinoma, Squamous Cell Laryngeal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Otorhinolaryngologic Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Foundation for Cancer Research and Education, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tirapazamine (SR259075)

Drug

Cisplatin

Drug

Radiation Therapy

Procedure

Primary outcomes

  1. Overall survival.

Secondary outcomes

  1. Time to locoregional failure.

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2006
Study completion
2006
First posted
Oct 14, 2004
Registry last updated
Feb 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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