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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00094081

Enrollment

861

Registered

2004-10-14

Start date

2002-10-31

Completion date

2006-09-30

Last updated

2010-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Neoplasms

Keywords

squamous cell carcinoma, oropharynx, oral cavity, larynx, hypopharynx

Brief summary

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

Interventions

DRUGtirapazamine (SR259075)

DRUGcisplatin

PROCEDURERadiation Therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Overall survival.	—

Secondary

Measure	Time frame
Time to locoregional failure.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026