Using Intensity-Modulated Radiation Therapy to Permit Sparing of Parotid Gland Function

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT00137475
First received: August 26, 2005
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

Radiotherapy is the primary treatment modality or an important adjunct treatment for many patients with H&N carcinoma. Local control is directly related to dose and to the technical accuracy with which the dose is delivered to the target volume. Traditional radiotherapy techniques result in significant doses being delivered to normal tissues adjacent to the target, including the spinal cord and salivary glands. This leaves the patient with significant acute and late normal tissue toxicity that impacts on both the ability to tolerate the actual treatment and on the patient's long-term quality of life. Recently, the investigators have used static conformal multisegmental intensity modulated radiotherapy (IMRT) for a comprehensive irradiation of head and neck cancer with dose sparing of uninvolved tissues. This has resulted in substantial preservation of major salivary gland function in many patients with primary sites in the oral pharynx, oral cavity, nasopharynx, and pyriform sinus. While the investigators' results to date have shown promising preservation of salivary flow, they do not know whether patients treated with IMRT have similar local control rates as those treated with standard radiotherapy. Some investigators have raised the concern that by giving a low radiation dose to areas adjacent to the target volume there is a risk of undertreating the disease. On the other hand, the IMRT delivered with this protocol (called "simultaneous integrated boost", or SIB) may improve local control rates by delivering the same biologically effective dose in a shorter overall time period. This is a phase I/II trial which seeks to establish the efficacy of IMRT for H&N cancer treatment, and to further investigate the relationship between radiation dose to the parotid glands, salivary flow, and quality of life.


Condition Intervention Phase
Head and Neck Cancer
Procedure: Intensity-Modulated Radiation Therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Feasibility/Efficacy Study Using Intensity-Modulated Radiation Therapy in Head and Neck (H&N) Cancer Patients to Permit Sparing of Parotid Gland Function

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta:

Primary Outcome Measures:
  • locoregional control rates
  • patterns of failure

Secondary Outcome Measures:
  • quality of life
  • saliva flow rates/xerostomia
  • overall survival

Enrollment: 130
Study Start Date: February 2002
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Squamous cell cancer of head and neck for radical/postoperative radiation therapy
  • American Joint Committee on Cancer (AJCC) stage I-IV with M0 and N0-2 disease
  • Karnofsky performance status (KPS) >= 70%

Exclusion Criteria:

  • M1 or N3 disease
  • Ineligibility for radiotherapy
  • Recent malignancy
  • Previous cancer or head and neck radiotherapy
  • Salivary gland dysfunction
  • Unwilling to provide informed consent
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00137475

Locations
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
AHS Cancer Control Alberta
Investigators
Principal Investigator: Rufus Scrimger, MD AHS Cancer Control Alberta
  More Information

No publications provided

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT00137475     History of Changes
Other Study ID Numbers: NA-15-0006 / 17086
Study First Received: August 26, 2005
Last Updated: February 3, 2014
Health Authority: Canada: Health Canada

Keywords provided by AHS Cancer Control Alberta:
IMRT
head and neck cancer
parotid sparing

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 29, 2014