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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This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT00363441
First received: August 9, 2006
Last updated: January 18, 2012
Last verified: January 2011
History of Changes
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:

U.S. FDA Resources

Further study details as provided by Alberta Health Services:

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

Enrollment: 0
  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

Sponsors and Collaborators
Alberta Health Services
Investigators
Principal Investigator: Harold P Lau, MD Tom Baker Cancer Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00363441     History of Changes
Other Study ID Numbers: 20313
Study First Received: August 9, 2006
Last Updated: January 18, 2012
Health Authority: Canada: Health Canada

Keywords provided by Alberta Health Services:
head and neck neoplasms
squamous cell cancer
intensity modulated radiotherapy

Additional relevant MeSH terms:
Neoplasms
Carcinoma, Squamous Cell
Neoplasms, Squamous Cell
Head and Neck Neoplasms
 Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site

ClinicalTrials.gov processed this record on May 23, 2013