Clinical trial NCT00174837: TRACE: Tirapazamine-Radiation And Cisplatin Evaluation
Official title: Phase III Randomized Trial of Concomitant Radiation, Cisplatin, and Tirapazamine Versus Concomitant Radiation and Cisplatin in Patients With Advanced Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Head and Neck Squamous Cell Carcinoma
Keywords: Tirapazamine
Head and Neck Cancer
Cisplatin
Radiation
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Groupe Oncologie Radiotherapie Tete et Cou
First posted: 2005-09-15
Enrollment: 317
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: Study period
Secondary outcomes:
measure: Failure Free Survival, Time To Loco-Regional Failure, Patterns of Failure
timeFrame: Study period
measure: Initial Response Rates at 2 Months After Completion of Chemoradiation Therapy, Final complete response (CR) Rate at Six Months After Completion of Therapy
timeFrame: Study period
measure: Change in QoL From Baseline, Percent of Patients Who Are Feeding Tube Dependent 12 Months After Completion of Therapy
timeFrame: Study period
measure: Toxicity and Safety
timeFrame: Study period
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis Administrative Office
state: New Jersey
city: Buenos Aires
country: Argentina
facility: Sanofi-Aventis Administrative Office
city: Cove
country: Australia
facility: Sanofi-Aventis Administrative Office
city: Laval
country: Canada
facility: Sanofi-Aventis Administrative Office
city: Santiago
country: Chile
facility: Sanofi-Aventis Administrative Office
city: Paris
country: France
facility: Sanofi-Aventis Administrative Office
city: Berlin
country: Germany
facility: Sanofi-Aventis Administrative Office
city: Causeway Bay
country: Hong Kong
facility: Sanofi-Aventis Administrative Office
city: Budapest
country: Hungary
facility: Sanofi-Aventis Administrative Office
city: Milan
country: Italy
facility: Sanofi-Aventis Administrative Office
city: Macquarie Park
country: New Zealand
facility: sanofi-aventis New Zealand administrative office
city: Warszawa
country: Poland
facility: Sanofi-Aventis Administrative Office
city: Singapore
country: Singapore
facility: Sanofi-Aventis Administrative Office
city: Midrand
country: South Africa
facility: Sanofi-Aventis Administrative Office
city: Barcelona
country: Spain
facility: Sanofi-Aventis Administrative Office
city: Geneva
country: Switzerland
facility: Sanofi-Aventis Administrative Office
city: Taipei
country: Taiwan
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References: