TRACE: Tirapazamine-Radiation And Cisplatin Evaluation

This study has been completed.
Sponsor:
Collaborator:
Groupe Oncologie Radiotherapie Tete et Cou
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00174837
First received: September 13, 2005
Last updated: January 15, 2009
Last verified: January 2009
  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 (SR259075)
Drug: cisplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Failure Free Survival, Time To Loco-Regional Failure, Patterns of Failure [ Time Frame: Study period ] [ Designated as safety issue: No ]
  • Initial Response Rates at 2 Months After Completion of Chemoradiation Therapy, Final CR Rate at Six Months After Completion of Therapy [ Time Frame: Study period ] [ Designated as safety issue: No ]
  • Change in QoL From Baseline, Percent of Patients Who Are Feeding Tube Dependent 12 Months After Completion of Therapy [ Time Frame: Study period ] [ Designated as safety issue: No ]
  • Toxicity and Safety [ Time Frame: Study period ] [ Designated as safety issue: Yes ]

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: 1 Drug: Tirapazamine (SR259075)
in combination with cisplatin and concomitant radiation
Active Comparator: 2 Drug: cisplatin
with concomitant radiation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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).
  • 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 ULN and AST/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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00174837     History of Changes
Other Study ID Numbers: EFC5512, SR259075
Study First Received: September 13, 2005
Last Updated: January 15, 2009
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Tirapazamine
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 28, 2014