TRACE: Tirapazamine-Radiation And Cisplatin Evaluation - Full Text View

Sponsors and Collaborators:	Sanofi-Aventis Groupe Oncologie Radiotherapie Tete et Cou
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00174837

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Cancer Head and Neck Cancer Radiation Therapy

Drug Information available for: Cisplatin Tirapazamine

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00174837

Show 17 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Groupe Oncologie Radiotherapie Tete et Cou

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

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

Keywords provided by Sanofi-Aventis:

Tirapazamine
Head and Neck Cancer
Cisplatin
Radiation

Study placed in the following topic categories:

Radiation-Sensitizing Agents
Cisplatin
Head and Neck Neoplasms
Epidermoid Carcinoma
Tirapazamine

Neoplasms, Squamous Cell
Squamous Cell Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Antineoplastic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents

Cisplatin
Head and Neck Neoplasms
Therapeutic Uses
Tirapazamine
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 02, 2009