Concomitant Radiation and Cisplatin With and Without Tirapazamine in Treatment of Advanced Head and Neck Cancer
Phase III Randomized Trial of Concomitant Radiation, Cisplatin, and Tirapazamine Versus Concomitant Radiation and Cisplatin in Patients With Advanced Head and Neck Cancer
2 other identifiers
interventional
861
1 country
10
Brief Summary
The trial will compare the efficacy and safety of concomitant chemoradiation with tirapazamine, cisplatin and radiation versus cisplatin and radiation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2002
Typical duration for phase_3
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2002
CompletedFirst Submitted
Initial submission to the registry
October 11, 2004
CompletedFirst Posted
Study publicly available on registry
October 14, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedFebruary 15, 2010
February 1, 2010
3.9 years
October 11, 2004
February 12, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival.
Secondary Outcomes (1)
Time to locoregional failure.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Metastatic Disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (10)
Foundation for Cancer Research and Education
Phoenix, Arizona, 85013, United States
Stanford University Medical Center
Palo Alto, California, 94305, United States
H-Lee Moffitt Cancer Center and Research
Tampa, Florida, 33612, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21231, United States
Harper Hospital
Detroit, Michigan, 48201, United States
VA New Jersey Health Care Medical Center
East Orange, New Jersey, 07018, United States
University of Rochester Medical Center
Rochester, New York, 14620, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Eastern Virginia Medical School
Norfolk, Virginia, 23507, United States
Related Publications (1)
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.
PMID: 27209505DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ICD CSD
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 11, 2004
First Posted
October 14, 2004
Study Start
October 1, 2002
Primary Completion
September 1, 2006
Study Completion
September 1, 2006
Last Updated
February 15, 2010
Record last verified: 2010-02