Intensity Modulated Radiation Therapy for Head and Neck Cancer
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.
Procedure: intensity modulated radiation therapy
Drug: cisplatinium and fluorouracil - standard treatment
|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|
- 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 ] [ Designated as safety issue: No ]
- -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
|Study Start Date:||June 2003|
|Estimated Study Completion Date:||June 2018|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00188877
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Andrew Bayley, MD||Princess Margaret Hospital, Canada|