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Clinical Trials/NCT00363441
NCT00363441WithdrawnPhase 2

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

Alberta Health services0 sitesStarted: August 15, 2006Last updated:
Conditions

Trial Snapshot

Phase
Phase 2
Status
Withdrawn
Primary Endpoint
Prevalence and severity of side effects according to Radiation Therapy Oncology Group

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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 Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other

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