Overview

This trial is active, not recruiting.

Condition nasopharyngeal neoplasms
Treatments intensity modulated radiation therapy, cisplatinium and fluorouracil - standard treatment
Phase phase 2
Sponsor University Health Network, Toronto
Collaborator Princess Margaret Hospital, Canada
Start date June 2003
End date June 2008
Trial size 44 participants
Trial identifier NCT00188877, UHN REB 03-0158-C

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
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 Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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.

Additional Information

Official title A Phase II Study of Intensity Modulated Radiation Therapy for Nasopharyngeal Cancer
Principal investigator Andrew Bayley, MD
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by University Health Network, Toronto.