Intensity Modulated Radiation Therapy for Head and Neck Cancer

Nasopharyngeal Neoplasms Clinical Trial

Official title:

A Phase II Study of Intensity Modulated Radiation Therapy for Nasopharyngeal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00188877
• Other study ID #: UHN REB 03-0158-C
• Status: Completed
• Phase: Phase 2
• Start date: June 2003
• Est. completion date: June 2019

Study information

• Verified date: November 2019
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 2019
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nasopharyngeal Neoplasms

Intervention

Procedure:
• intensity modulated radiation therapy

Drug:
• cisplatinium and fluorouracil - standard treatment

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Princess Margaret Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		q2 monthly during year 1, q3 monthly during year 2; q4 monthly during year 3; q6 monthly during year 4 and annually thereafter
Secondary	-the ability of IMRT techniques to spare long term xerostomia as evaluated by saliva flow rates.
Secondary	-the nature and prevalence of acute and late side effects and their relationship to local dose.
Secondary	-the dosimetric differences between conventional "forward planned" two dimensional plans, three dimensional plans and Intensity modulated radiation therapy.
Secondary	-evaluation of failure with respect to the doses in the region of the failure
Secondary	-quality of life measurements in patients after receiving IMRT for the treatment of nasopharyngeal carcinoma