- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00363441
A Study of Conventional 3D Radiation vs. Intensity-Modulated Radiation in Squamous Cell Cancer of the Head and Neck
January 18, 2012 updated by: Alberta Health services
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
This is a randomized study of conventional 3d radiation versus intensity-modulated radiation in squamous cell cancer of the head and neck.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Harold P Lau, MD, Tom Baker Cancer Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
August 9, 2006
First Submitted That Met QC Criteria
August 11, 2006
First Posted (Estimate)
August 15, 2006
Study Record Updates
Last Update Posted (Estimate)
January 19, 2012
Last Update Submitted That Met QC Criteria
January 18, 2012
Last Verified
January 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20313
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Head and Neck Neoplasms
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Robert FerrisAmgenCompletedHead and Neck Cancer | Cancer of Head and Neck | Head Cancer | Neck Cancer | Neoplasms, Head and Neck | Cancer of the Head and Neck | Cancer of Neck | Upper Aerodigestive Tract Neoplasms | Neck Neoplasms | Cancer of the Head | Cancer of the Neck | UADT Neoplasms | Cancer of Head | Head Neoplasms | Head, Neck Neoplasms | Neoplasms, Head and other conditionsUnited States
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Assiut UniversityRecruitingHead and Neck Cancer | Head and Neck Neoplasms | Cancer of Head and Neck | Neoplasms, Head and Neck | Cancer of the Head and NeckEgypt
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IRCCS Policlinico S. MatteoNestlé Health Science Spain; Akern SrlCompletedHead-neck CancerItaly
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University of California, San FranciscoCompleted
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Thomas Jefferson UniversityCompletedHead and Neck CarcinomaUnited States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)TerminatedHead And Neck CancerUnited States
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AZ Sint-Jan AVRecruiting
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IntraGel TherapeuticsNot yet recruiting
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingHead and Neck CarcinomaUnited States
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Gustave Roussy, Cancer Campus, Grand ParisActive, not recruiting
Clinical Trials on Intensity Modulated Radiotherapy
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National University Hospital, SingaporeTan Tock Seng HospitalUnknown
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National Cancer Institute (NCI)TerminatedLocally Recurrent Head and Neck Squamous Cell Carcinoma | Nasopharyngeal Squamous Cell Carcinoma | Sinonasal Squamous Cell CarcinomaUnited States
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Centre hospitalier de l'Université de Montréal...CompletedQuality of Life | Pain | Neoplasm Metastasis | Radiotherapy Side Effect
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M.D. Anderson Cancer CenterUnknownProstate CancerUnited States
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University of MiamiCompletedProstate Cancer | Prostate AdenocarcinomaUnited States
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Jiangsu Cancer Institute & HospitalCompletedNasopharyngeal Carcinoma | Radiation-Induced Temporal Lobe InjuryChina
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University Medical Center GroningenCompletedHead and Neck CancerNetherlands
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Sun Yat-sen UniversityUnknownCervical Cancer | Radiation Toxicity | Recurrent Cervical CarcinomaChina
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Royal Marsden NHS Foundation TrustCompletedOropharyngeal Squamous Cell Cancer | Hypopharyngeal Squamous Cell CancerUnited Kingdom
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New Mexico Cancer Care AllianceCompletedNeoplasm Metastasis | Central Nervous System MetastasesUnited States