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TRACE: Tirapazamine-Radiation And Cisplatin Evaluation (TRACE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00174837
First Posted: September 15, 2005
Last Update Posted: May 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Groupe Oncologie Radiotherapie Tete et Cou
Information provided by (Responsible Party):
Sanofi
  Purpose
The trial will compare the efficacy and safety of concomitant chemoradiation with tirapazamine, cisplatin and radiation versus cisplatin and radiation.

Condition Intervention Phase
Head and Neck Squamous Cell Carcinoma Drug: Tirapazamine Drug: Cisplatin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Study period ]

Secondary Outcome Measures:
  • Failure Free Survival, Time To Loco-Regional Failure, Patterns of Failure [ Time Frame: 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 [ Time Frame: Study period ]
  • Change in QoL From Baseline, Percent of Patients Who Are Feeding Tube Dependent 12 Months After Completion of Therapy [ Time Frame: Study period ]
  • Toxicity and Safety [ Time Frame: Study period ]

Enrollment: 317
Study Start Date: April 2005
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tirapazamine + Cisplatin Drug: Tirapazamine
in combination with cisplatin and concomitant radiation
Other Name: SR259075
Drug: Cisplatin
with concomitant radiation
Active Comparator: Cisplatin Drug: Cisplatin
with concomitant radiation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00174837


  Show 17 Study Locations
Sponsors and Collaborators
Sanofi
Groupe Oncologie Radiotherapie Tete et Cou
Investigators
Study Director: ICD CSD Sanofi
  More Information

Additional Information:
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00174837     History of Changes
Other Study ID Numbers: EFC5512
SR259075
First Submitted: September 13, 2005
First Posted: September 15, 2005
Last Update Posted: May 26, 2016
Last Verified: April 2016

Keywords provided by Sanofi:
Tirapazamine
Head and Neck Cancer
Cisplatin
Radiation

Additional relevant MeSH terms:
Tirapazamine
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Cisplatin
Antineoplastic Agents