MedTrace Logo

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

NCT00137475 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2016-02-26

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Intensity-Modulated Radiation Therapy

Sponsors & Collaborators

  • AHS Cancer Control Alberta

    lead OTHER

Principal Investigators

  • Rufus Scrimger, MD · AHS Cancer Control Alberta

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-02-28
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00137475 on ClinicalTrials.gov