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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/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
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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
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Secondary ID [1]
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SR259075
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Secondary ID [2]
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EFC5512
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Universal Trial Number (UTN)
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Trial acronym
TRACE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Head and Neck Squamous Cell Carcinoma
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Condition category
Condition code
Cancer
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Head and neck
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall survival
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Assessment method [1]
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Timepoint [1]
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Study period
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Secondary outcome [1]
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Failure Free Survival, Time To Loco-Regional Failure, Patterns of Failure
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Assessment method [1]
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Study period
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Secondary outcome [2]
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Initial Response Rates at 2 Months After Completion of Chemoradiation Therapy, Final complete response (CR) Rate at Six Months After Completion of Therapy
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Assessment method [2]
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Timepoint [2]
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Study period
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Secondary outcome [3]
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Change in QoL From Baseline, Percent of Patients Who Are Feeding Tube Dependent 12 Months After Completion of Therapy
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Assessment method [3]
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Timepoint [3]
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Secondary outcome [4]
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Toxicity and Safety
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Assessment method [4]
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Timepoint [4]
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Study period
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2008
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Sample size
Target
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Accrual to date
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Final
317
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Sanofi-Aventis Administrative Office - Cove
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Recruitment postcode(s) [1]
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- Cove
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Recruitment outside Australia
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United States of America
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State/province [1]
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New Jersey
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Argentina
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Buenos Aires
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Canada
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Laval
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Chile
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Santiago
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France
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Paris
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Germany
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Berlin
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Hong Kong
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Causeway Bay
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Hungary
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Budapest
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Italy
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Milan
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New Zealand
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Macquarie Park
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Poland
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Warszawa
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Singapore
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Singapore
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South Africa
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Midrand
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Spain
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Barcelona
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Switzerland
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Geneva
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Taiwan
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State/province [16]
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Taipei
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Sanofi
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Groupe Oncologie Radiotherapie Tete et Cou
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The trial will compare the efficacy and safety of concomitant chemoradiation with
tirapazamine, cisplatin and radiation versus cisplatin and radiation.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00174837
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Sanofi
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00174837
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