Intensity Modulated Radiation Therapy for Head and Neck Cancer
Primary Purpose
Nasopharyngeal Neoplasms
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
intensity modulated radiation therapy
cisplatinium and fluorouracil - standard treatment
Sponsored by
About this trial
This is an interventional treatment trial for Nasopharyngeal Neoplasms
Eligibility 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.
Sites / Locations
- Princess Margaret Hospital
Outcomes
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
-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
Full Information
NCT ID
NCT00188877
First Posted
September 12, 2005
Last Updated
November 28, 2019
Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada
1. Study Identification
Unique Protocol Identification Number
NCT00188877
Brief Title
Intensity Modulated Radiation Therapy for Head and Neck Cancer
Official Title
A Phase II Study of Intensity Modulated Radiation Therapy for Nasopharyngeal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
June 2003 (Actual)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
intensity modulated radiation therapy
Intervention Type
Drug
Intervention Name(s)
cisplatinium and fluorouracil - standard treatment
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
-the ability of IMRT techniques to spare long term xerostomia as evaluated by saliva flow rates.
Title
-the nature and prevalence of acute and late side effects and their relationship to local dose.
Title
-the dosimetric differences between conventional "forward planned" two dimensional plans, three dimensional plans and Intensity modulated radiation therapy.
Title
-evaluation of failure with respect to the doses in the region of the failure
Title
-quality of life measurements in patients after receiving IMRT for the treatment of nasopharyngeal carcinoma
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Bayley, MD
Organizational Affiliation
Princess Margaret Hospital, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Intensity Modulated Radiation Therapy for Head and Neck Cancer
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