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TRACE: Tirapazamine-Radiation And Cisplatin Evaluation (TRACE)

Primary Purpose

Head and Neck Squamous Cell Carcinoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tirapazamine
Cisplatin
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Squamous Cell Carcinoma focused on measuring Tirapazamine, Head and Neck Cancer, Cisplatin, Radiation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • sanofi-aventis New Zealand administrative office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tirapazamine + Cisplatin

Cisplatin

Arm Description

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Failure Free Survival, Time To Loco-Regional Failure, Patterns of Failure
Initial Response Rates at 2 Months After Completion of Chemoradiation Therapy, Final complete response (CR) Rate at Six Months After Completion of Therapy
Change in QoL From Baseline, Percent of Patients Who Are Feeding Tube Dependent 12 Months After Completion of Therapy
Toxicity and Safety

Full Information

First Posted
September 13, 2005
Last Updated
April 27, 2016
Sponsor
Sanofi
Collaborators
Groupe Oncologie Radiotherapie Tete et Cou
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1. Study Identification

Unique Protocol Identification Number
NCT00174837
Brief Title
TRACE: Tirapazamine-Radiation And Cisplatin Evaluation
Acronym
TRACE
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 Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
Collaborators
Groupe Oncologie Radiotherapie Tete et Cou

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Squamous Cell Carcinoma
Keywords
Tirapazamine, Head and Neck Cancer, Cisplatin, Radiation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
317 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tirapazamine + Cisplatin
Arm Type
Experimental
Arm Title
Cisplatin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Tirapazamine
Other Intervention Name(s)
SR259075
Intervention Description
in combination with cisplatin and concomitant radiation
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
with concomitant radiation
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
Study period
Secondary Outcome Measure Information:
Title
Failure Free Survival, Time To Loco-Regional Failure, Patterns of Failure
Time Frame
Study period
Title
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
Title
Change in QoL From Baseline, Percent of Patients Who Are Feeding Tube Dependent 12 Months After Completion of Therapy
Time Frame
Study period
Title
Toxicity and Safety
Time Frame
Study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
Facility Name
Sanofi-Aventis Administrative Office
City
Buenos Aires
Country
Argentina
Facility Name
Sanofi-Aventis Administrative Office
City
Cove
Country
Australia
Facility Name
Sanofi-Aventis Administrative Office
City
Laval
Country
Canada
Facility Name
Sanofi-Aventis Administrative Office
City
Santiago
Country
Chile
Facility Name
Sanofi-Aventis Administrative Office
City
Paris
Country
France
Facility Name
Sanofi-Aventis Administrative Office
City
Berlin
Country
Germany
Facility Name
Sanofi-Aventis Administrative Office
City
Causeway Bay
Country
Hong Kong
Facility Name
Sanofi-Aventis Administrative Office
City
Budapest
Country
Hungary
Facility Name
Sanofi-Aventis Administrative Office
City
Milan
Country
Italy
Facility Name
sanofi-aventis New Zealand administrative office
City
Macquarie Park
Country
New Zealand
Facility Name
Sanofi-Aventis Administrative Office
City
Warszawa
Country
Poland
Facility Name
Sanofi-Aventis Administrative Office
City
Singapore
Country
Singapore
Facility Name
Sanofi-Aventis Administrative Office
City
Midrand
Country
South Africa
Facility Name
Sanofi-Aventis Administrative Office
City
Barcelona
Country
Spain
Facility Name
Sanofi-Aventis Administrative Office
City
Geneva
Country
Switzerland
Facility Name
Sanofi-Aventis Administrative Office
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Links:
URL
http://www.sanofi-aventis.com
Description
Related Info

Learn more about this trial

TRACE: Tirapazamine-Radiation And Cisplatin Evaluation

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