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

CompletadoFase 3ClinicalTrials.gov

ID: NCT00174837Tipo: INTERVENTIONALInicio: 1 de abr de 2005Fin estimado: 1 de ene de 2008

Traducción no disponible, mostrando original

Resumen

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

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

Clinically significant hearing impairment
Significant cardiac disease
Metastatic Disease
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

Intervenciones

drug

Tirapazamine

in combination with cisplatin and concomitant radiation

drug

Cisplatin

with concomitant radiation

Ubicaciones

Sanofi-Aventis Administrative Office

Buenos Aires, Argentina

Patrocinadores

PrincipalSanofi

ColaboradorGroupe Oncologie Radiotherapie Tete et Cou

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