Intensity Modulated Radiation Therapy for Head and Neck Cancer

NCT ID: NCT00188877

Last Updated: 2019-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2019-06-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

intensity modulated radiation therapy

Intervention Type: PROCEDURE

cisplatinium and fluorouracil - standard treatment

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Princess Margaret Hospital, Canada

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Bayley, MD

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Hospital, Canada

Locations

Princess Margaret Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

UHN REB 03-0158-C

Identifier Type: -

Identifier Source: org_study_id