NCT00363441

Brief Summary

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

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2006

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 15, 2006

Completed
Last Updated

January 19, 2012

Status Verified

January 1, 2011

First QC Date

August 9, 2006

Last Update Submit

January 18, 2012

Conditions

Head and Neck NeoplasmsSquamous Cell Cancer

Keywords

head and neck neoplasmssquamous cell cancerintensity modulated radiotherapy

Outcome Measures

Primary Outcomes (2)

  • 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

Interventions

Intensity Modulated RadiotherapyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Head and Neck NeoplasmsNeoplasms, Squamous Cell

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Radiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Study Officials

  • Harold P Lau, MD

    Tom Baker Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 9, 2006

First Posted

August 15, 2006

Last Updated

January 19, 2012

Record last verified: 2011-01