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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00174837




Registration number
NCT00174837
Ethics application status
Date submitted
13/09/2005
Date registered
15/09/2005
Date last updated
26/05/2016

Titles & IDs
Public title
TRACE: Tirapazamine-Radiation And Cisplatin Evaluation
Scientific title
Phase III Randomized Trial of Concomitant Radiation, Cisplatin, and Tirapazamine Versus Concomitant Radiation and Cisplatin in Patients With Advanced Head and Neck Cancer
Secondary ID [1] 0 0
SR259075
Secondary ID [2] 0 0
EFC5512
Universal Trial Number (UTN)
Trial acronym
TRACE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Squamous Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tirapazamine
Treatment: Drugs - Cisplatin

Experimental: Tirapazamine + Cisplatin -

Active Comparator: Cisplatin -


Treatment: Drugs: Tirapazamine
in combination with cisplatin and concomitant radiation

Treatment: Drugs: Cisplatin
with concomitant radiation

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival
Timepoint [1] 0 0
Study period
Secondary outcome [1] 0 0
Failure Free Survival, Time To Loco-Regional Failure, Patterns of Failure
Timepoint [1] 0 0
Study period
Secondary outcome [2] 0 0
Initial Response Rates at 2 Months After Completion of Chemoradiation Therapy, Final complete response (CR) Rate at Six Months After Completion of Therapy
Timepoint [2] 0 0
Study period
Secondary outcome [3] 0 0
Change in QoL From Baseline, Percent of Patients Who Are Feeding Tube Dependent 12 Months After Completion of Therapy
Timepoint [3] 0 0
Study period
Secondary outcome [4] 0 0
Toxicity and Safety
Timepoint [4] 0 0
Study period

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sanofi-Aventis Administrative Office - Cove
Recruitment postcode(s) [1] 0 0
- Cove
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New Jersey
Country [2] 0 0
Argentina
State/province [2] 0 0
Buenos Aires
Country [3] 0 0
Canada
State/province [3] 0 0
Laval
Country [4] 0 0
Chile
State/province [4] 0 0
Santiago
Country [5] 0 0
France
State/province [5] 0 0
Paris
Country [6] 0 0
Germany
State/province [6] 0 0
Berlin
Country [7] 0 0
Hong Kong
State/province [7] 0 0
Causeway Bay
Country [8] 0 0
Hungary
State/province [8] 0 0
Budapest
Country [9] 0 0
Italy
State/province [9] 0 0
Milan
Country [10] 0 0
New Zealand
State/province [10] 0 0
Macquarie Park
Country [11] 0 0
Poland
State/province [11] 0 0
Warszawa
Country [12] 0 0
Singapore
State/province [12] 0 0
Singapore
Country [13] 0 0
South Africa
State/province [13] 0 0
Midrand
Country [14] 0 0
Spain
State/province [14] 0 0
Barcelona
Country [15] 0 0
Switzerland
State/province [15] 0 0
Geneva
Country [16] 0 0
Taiwan
State/province [16] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Groupe Oncologie Radiotherapie Tete et Cou
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The trial will compare the efficacy and safety of concomitant chemoradiation with
tirapazamine, cisplatin and radiation versus cisplatin and radiation.
Trial website
https://clinicaltrials.gov/show/NCT00174837
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ICD CSD
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications