TRACE: Tirapazamine-Radiation And Cisplatin Evaluation (TRACE)

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. Identifier: NCT00174837
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : May 26, 2016
Groupe Oncologie Radiotherapie Tete et Cou
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Head and Neck Squamous Cell Carcinoma Drug: Tirapazamine Drug: Cisplatin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 317 participants
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
Study Start Date : April 2005
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. Failure Free Survival, Time To Loco-Regional Failure, Patterns of Failure [ Time Frame: Study period ]
  2. 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 ]
  3. Change in QoL From Baseline, Percent of Patients Who Are Feeding Tube Dependent 12 Months After Completion of Therapy [ Time Frame: Study period ]
  4. Toxicity and Safety [ Time Frame: Study period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00174837

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

Additional Information:
Responsible Party: Sanofi Identifier: NCT00174837     History of Changes
Other Study ID Numbers: EFC5512
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: May 26, 2016
Last Verified: April 2016

Keywords provided by Sanofi:
Head and Neck Cancer

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