TRACE: Tirapazamine-Radiation And Cisplatin Evaluation

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

NCT00174837

Acronym

TRACE

Enrollment

317

Registered

2005-09-15

Start date

2005-04-30

Completion date

2008-01-31

Last updated

2016-05-26

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

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

Tirapazamine, Head and Neck Cancer, Cisplatin, Radiation

Brief summary

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

Interventions

DRUGCisplatin

with concomitant radiation

DRUGTirapazamine

in combination with cisplatin and concomitant radiation

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 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.

Exclusion criteria

* 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 * Clinically significant hearing impairment * Significant cardiac disease

Design outcomes

Primary

Measure	Time frame
Overall survival	Study period

Secondary

Measure	Time frame
Failure Free Survival, Time To Loco-Regional Failure, Patterns of Failure	Study period
Initial Response Rates at 2 Months After Completion of Chemoradiation Therapy, Final complete response (CR) Rate at Six Months After Completion of Therapy	Study period
Change in QoL From Baseline, Percent of Patients Who Are Feeding Tube Dependent 12 Months After Completion of Therapy	Study period
Toxicity and Safety	Study period

Countries

Argentina, Australia, Canada, Chile, France, Germany, Hong Kong, Hungary, Italy, New Zealand, Poland, Singapore, South Africa, Spain, Switzerland, Taiwan, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026