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

February 12, 2010 updated by: Sanofi

Phase III Randomized Trial of Concomitant Radiation, Cisplatin, and Tirapazamine Versus Concomitant Radiation and Cisplatin in Patients With Advanced Head and Neck Cancer

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

861

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Foundation for Cancer Research and Education
    • California
      • Palo Alto, California, United States, 94305
        • Stanford University Medical Center
    • Florida
      • Tampa, Florida, United States, 33612
        • H-Lee Moffitt Cancer Center and Research
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Johns Hopkins Hospital
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Harper Hospital
    • New Jersey
      • East Orange, New Jersey, United States, 07018
        • VA New Jersey Health Care Medical Center
    • New York
      • Rochester, New York, United States, 14620
        • University of Rochester Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Eastern Virginia Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall survival.

Secondary Outcome Measures

Outcome Measure
Time to locoregional failure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

October 11, 2004

First Submitted That Met QC Criteria

October 13, 2004

First Posted (Estimate)

October 14, 2004

Study Record Updates

Last Update Posted (Estimate)

February 15, 2010

Last Update Submitted That Met QC Criteria

February 12, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC4690
  • SR259075

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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