Intensity Modulated Radiation Therapy for Head and Neck Cancer

NCT00188877 | Completed Phase 2

• 1 other identifier: UHN REB 03-0158-C
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• -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

Interventions

intensity modulated radiation therapy PROCEDURE

cisplatinium and fluorouracil - standard treatment DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Princess Margaret Hospital, Canada: collaborator

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Nasopharyngeal Neoplasms

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Andrew Bayley, MD

  Princess Margaret Hospital, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: June 1, 2003
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2019
• Last Updated: December 2, 2019

Record last verified: 2019-11

Locations

CA (1)