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Concomitant Radiation and Cisplatin With and Without Tirapazamine in Treatment of Advanced Head and Neck Cancer

Primary Purpose

Head and Neck Neoplasms

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
tirapazamine (SR259075)
cisplatin
Radiation Therapy
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Neoplasms focused on measuring squamous cell carcinoma, oropharynx, oral cavity, larynx, hypopharynx

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). 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

Sites / Locations

  • Foundation for Cancer Research and Education
  • Stanford University Medical Center
  • H-Lee Moffitt Cancer Center and Research
  • University of Chicago Medical Center
  • Johns Hopkins Hospital
  • Harper Hospital
  • VA New Jersey Health Care Medical Center
  • University of Rochester Medical Center
  • Medical University of South Carolina
  • Eastern Virginia Medical School

Outcomes

Primary Outcome Measures

Overall survival.

Secondary Outcome Measures

Time to locoregional failure.

Full Information

First Posted
October 11, 2004
Last Updated
February 12, 2010
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00094081
Brief Title
Concomitant Radiation and Cisplatin With and Without Tirapazamine in Treatment of Advanced Head and Neck Cancer
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
February 2010
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

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 Neoplasms
Keywords
squamous cell carcinoma, oropharynx, oral cavity, larynx, hypopharynx

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
tirapazamine (SR259075)
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Procedure
Intervention Name(s)
Radiation Therapy
Primary Outcome Measure Information:
Title
Overall survival.
Secondary Outcome Measure Information:
Title
Time to locoregional failure.

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). 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Foundation for Cancer Research and Education
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Stanford University Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
H-Lee Moffitt Cancer Center and Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Harper Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
VA New Jersey Health Care Medical Center
City
East Orange
State/Province
New Jersey
ZIP/Postal Code
07018
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Eastern Virginia Medical School
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27209505
Citation
Ringash J, Fisher R, Peters L, Trotti A, O'Sullivan B, Corry J, Kenny L, Nuyts S, Wratten C, Rischin D. Effect of p16 Status on the Quality-of-Life Experience During Chemoradiation for Locally Advanced Oropharyngeal Cancer: A Substudy of Randomized Trial Trans-Tasman Radiation Oncology Group (TROG) 02.02 (HeadSTART). Int J Radiat Oncol Biol Phys. 2017 Mar 15;97(4):678-686. doi: 10.1016/j.ijrobp.2016.03.017. Epub 2016 Mar 23. Erratum In: Int J Radiat Oncol Biol Phys. 2017 Sep 1;99(1):244.
Results Reference
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Concomitant Radiation and Cisplatin With and Without Tirapazamine in Treatment of Advanced Head and Neck Cancer

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