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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00137475
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : February 26, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Head and Neck Cancer Procedure: Intensity-Modulated Radiation Therapy Phase 1 Phase 2

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2002
Primary Completion Date : August 2012
Study Completion Date : August 2012

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U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. locoregional control rates
  2. patterns of failure

Secondary Outcome Measures :
  1. quality of life
  2. saliva flow rates/xerostomia
  3. overall survival

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT00137475     History of Changes
Other Study ID Numbers: NA-15-0006 / 17086
First Posted: August 30, 2005    Key Record Dates
Last Update Posted: February 26, 2016
Last Verified: February 2014

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

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