Back to resultsA Study of Conventional 3D Radiation vs. Intensity-Modulated Radiation in Squamous Cell Cancer of the Head and Neck
Primary Purpose
Head and Neck Neoplasms, Squamous Cell Cancer
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Intensity Modulated Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Neoplasms focused on measuring head and neck neoplasms, squamous cell cancer, intensity modulated radiotherapy
Eligibility Criteria
Inclusion Criteria: histologically proven squamous cell carcinoma of the head and neck or squamous cell cancer to the neck from an unknown head and neck primary site, stage I-IV disease which is M0, age greater than 18 years, KPS greater than 70, signed study-specific consent Exclusion Criteria: M1; bilateral N3 disease; primary greater than 10cm; salivary gland disease; life expectancy less than 2 years; prior radiotherapy to the head and neck; no signed study-specific consent form
Sites / Locations
Outcomes
Primary Outcome Measures
Prevalence and severity of side effects according to Radiation Therapy Oncology Group
scales and CTCAE version 3.0 for acute and chronic radiation toxicities, local control rates
Secondary Outcome Measures
Full Information
NCT ID
NCT00363441
First Posted
August 9, 2006
Last Updated
January 18, 2012
Sponsor
Alberta Health services
1. Study Identification
Unique Protocol Identification Number
NCT00363441
Brief Title
A Study of Conventional 3D Radiation vs. Intensity-Modulated Radiation in Squamous Cell Cancer of the Head and Neck
Official Title
A Randomized Phase II Study of Conventional 3D Radiation (3DCRT) Versus Intensity-Modulated Radiation (IMRT) in Squamous Cell Cancer of the Head and Neck (SCCHN): Pilot Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Withdrawn
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Alberta Health services
4. Oversight
5. Study Description
Brief Summary
This is a randomized study of conventional 3d radiation versus intensity-modulated radiation in squamous cell cancer of the head and neck.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms, Squamous Cell Cancer
Keywords
head and neck neoplasms, squamous cell cancer, intensity modulated radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Intensity Modulated Radiotherapy
Primary Outcome Measure Information:
Title
Prevalence and severity of side effects according to Radiation Therapy Oncology Group
Title
scales and CTCAE version 3.0 for acute and chronic radiation toxicities, local control rates
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
histologically proven squamous cell carcinoma of the head and neck or squamous cell cancer to the neck from an unknown head and neck primary site, stage I-IV disease which is M0, age greater than 18 years, KPS greater than 70, signed study-specific consent
Exclusion Criteria:
M1; bilateral N3 disease; primary greater than 10cm; salivary gland disease; life expectancy less than 2 years; prior radiotherapy to the head and neck; no signed study-specific consent form
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harold P Lau, MD
Organizational Affiliation
Tom Baker Cancer Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
A Study of Conventional 3D Radiation vs. Intensity-Modulated Radiation in Squamous Cell Cancer of the Head and Neck
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