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Intensity Modulated Radiation Therapy for Head and Neck Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00188877
First received: September 12, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Intensity Modulated Radiation Therapy for Nasopharyngeal Cancer

Resource links provided by NLM:

U.S. FDA Resources

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

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

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

ClinicalTrials.gov processed this record on May 19, 2013