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Intensity Modulated Radiation Therapy for Head and Neck Cancer
This study is currently recruiting participants.
Verified by University Health Network, Toronto, September 2005
First Received: September 12, 2005   No Changes Posted
Sponsors and Collaborators: University Health Network, Toronto
Princess Margaret Hospital, Canada
Information provided by: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00188877
  Purpose

Many normal tissues, including the eyes, brain, and spinal cord are very close to cancers in the nasopharynx. The dose of radiation delivered to the cancer is limited by tolerance of these normal tissues. Standard radiation treatment techniques using three or four radiation beams cannot avoid delivering some dose of radiation to these normal tissues that do not need to get radiation. Intensity Modulated Radiation Therapy (IMRT) uses many hundreds of computer-controlled radiation beams aimed at your cancer to try to lower the amount of radiation that normal tissues receive, while still delivering the desired amount of radiation to your cancer and to areas that your doctor thinks may have cancer cells.

The doctors at Princess Margaret Hospital are conducting this study in order to test whether the use of IMRT techniques can improve the chance of controlling your cancer in the head and neck region.


Condition Intervention Phase
Nasopharyngeal Neoplasms
Procedure: intensity modulated radiation therapy
Drug: cisplatinium and fluorouracil - standard treatment
Phase II

MedlinePlus related topics: Cancer Head and Neck Cancer Radiation Therapy
Drug Information available for: Fluorouracil
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase II Study of Intensity Modulated Radiation Therapy for Nasopharyngeal Cancer

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • The primary objective of this study is to evaluate 3 year local progression free survival in patients with nasopharyngeal carcinoma treated with Intensity Modulated Radiation Therapy (IMRT) techniques.

Secondary Outcome Measures:
  • To evaluate:
  • -the ability of IMRT techniques to spare long term xerostomia as evaluated by saliva flow rates.
  • -the nature and prevalence of acute and late side effects and their relationship to local dose.
  • -the dosimetric differences between conventional “forward planned” two dimensional plans, three dimensional plans and Intensity modulated radiation therapy.
  • -evaluation of failure with respect to the doses in the region of the failure
  • -quality of life measurements in patients after receiving IMRT for the treatment of nasopharyngeal carcinoma

Estimated Enrollment: 44
Study Start Date: June 2003
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed histopathologic diagnosis of nasopharyngeal squamous cell carcinoma requiring primary radiation
  • less than 70 yrs of age
  • Stage T1-T4; N0-N3; M0
  • KPS less than 70
  • no prior RT to H&N or chemotherapy for H&N
  • no other malignancy except non-melanomatous skin cancer
  • no distant mets
  • no contraindication to RT or chemotherapy
  • adequate organ function
  • informed consent

Exclusion Criteria

  • Major medical or psychiatric illness, which would interfere with either completion of therapy and follow-up or with full and complete understanding of the risks and potential complications of the therapy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00188877

Contacts
Contact: Andrew Bayley, MD 416-946-2919 andrew.bayley@rmp.uhn.on.ca

Locations
Canada, Ontario
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Andrew Bayley, MD     416-946-2919     andrew.bayley@rmp.uhn.on.ca    
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Investigators
Principal Investigator: Andrew Bayley, MD Princess Margaret Hospital, Canada
  More Information

No publications provided

Study ID Numbers: UHN REB 03-0158-C
Study First Received: September 12, 2005
Last Updated: September 12, 2005
ClinicalTrials.gov Identifier: NCT00188877     History of Changes
Health Authority: Canada: Ethics Review Committee

Study placed in the following topic categories:
Antimetabolites
Nasopharyngeal Carcinoma
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Immunologic Factors
Fluorouracil
Head and Neck Neoplasms
Pharyngeal Neoplasms
Stomatognathic Diseases
Immunosuppressive Agents
Pharyngeal Diseases
Nasopharyngeal Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Otorhinolaryngologic Neoplasms
Otorhinolaryngologic Diseases
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Pharyngeal Neoplasms
Immunosuppressive Agents
Pharyngeal Diseases
Pharmacologic Actions
Nasopharyngeal Neoplasms
Neoplasms
Neoplasms by Site
Therapeutic Uses
Head and Neck Neoplasms
Fluorouracil
Nasopharyngeal Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 07, 2009