Intensity Modulated Radiation Therapy for Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00188877
Recruitment Status : Active, not recruiting
First Posted : September 16, 2005
Last Update Posted : September 25, 2017
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:

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 or disease Intervention/treatment Phase
Nasopharyngeal Neoplasms Procedure: intensity modulated radiation therapy Drug: cisplatinium and fluorouracil - standard treatment Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Intensity Modulated Radiation Therapy for Nasopharyngeal Cancer
Study Start Date : June 2003
Actual Primary Completion Date : June 2008
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. 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. [ Time Frame: q2 monthly during year 1, q3 monthly during year 2; q4 monthly during year 3; q6 monthly during year 4 and annually thereafter ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00188877

Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Principal Investigator: Andrew Bayley, MD Princess Margaret Hospital, Canada

Responsible Party: University Health Network, Toronto Identifier: NCT00188877     History of Changes
Other Study ID Numbers: UHN REB 03-0158-C
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017

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