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

This study has been withdrawn prior to recruitment.

First Received: August 9, 2006 Last Updated: January 10, 2007 History of Changes

Sponsored by:	Alberta Cancer Board
Information provided by:	Alberta Cancer Board
ClinicalTrials.gov Identifier:	NCT00363441

Purpose

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

Condition	Intervention	Phase
Head and Neck Neoplasms Squamous Cell Cancer	Procedure: Intensity Modulated Radiotherapy	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer Radiation Therapy

Further study details as provided by Alberta Cancer Board:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00363441

Locations

Sponsors and Collaborators

Alberta Cancer Board

Investigators

Principal Investigator:

Harold P Lau, MD

Tom Baker Cancer Center

More Information

No publications provided

Study ID Numbers:	20313
Study First Received:	August 9, 2006
Last Updated:	January 10, 2007
ClinicalTrials.gov Identifier:	NCT00363441 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Alberta Cancer Board:

head and neck neoplasms
squamous cell cancer
intensity modulated radiotherapy

Study placed in the following topic categories:

Head and Neck Neoplasms
Epidermoid Carcinoma
Neoplasms, Squamous Cell
Squamous Cell Carcinoma

Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Head and Neck Neoplasms

Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on September 02, 2009