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NCT00363441 Clinical Trial

A Study of Conventional 3D Radiation vs. Intensity-Modulated Radiation in Squamous Cell Cancer of the Head and Neck

Head and Neck Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00363441
Other study ID # 20313
Secondary ID
Status Withdrawn
Phase Phase 2/Phase 3
First received August 9, 2006
Last updated January 18, 2012

Study information
Verified date January 2011
Source AHS Cancer Control Alberta
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

This is a randomized study of conventional 3d radiation versus intensity-modulated radiation in squamous cell cancer of the head and neck.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Intensity Modulated Radiotherapy

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Alberta Health Services

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence and severity of side effects according to Radiation Therapy Oncology Group
Primary scales and CTCAE version 3.0 for acute and chronic radiation toxicities, local control rates
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