A Feasibility Study of Adaptive Intensity-Modulated Radiation Therapy (IMRT)

May 22, 2013 updated by: Washington University School of Medicine

A Feasibility Study of Adaptive Intensity-Modulated Radiation Therapy in the Definitive Treatment of Head-and-Neck Cancer

Patients with head and neck cancer and are schedule to receive standard radiation therapy known as IMRT to treat cancer

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

In this study, we will plan additional measurements of the position of the patient's organs weekly during radiation treatment. We will analyze these measurements in order to evaluate whether we need to adjust our treatment procedures for the remainder of the treatments. We might adjust the dose of radiation received to specific organs in order to try to minimize the amount of radiation the healthy tissue receives.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age >= 18
  • Karnofsky Performance Status of >= 60
  • New diagnosis of head-and-neck cancer, all subsites included (i.e. nasopharynx, oropharynx, oral cavity, hypopharynx, larynx.)
  • All stages with measurable gross disease (>= 1.0 cm) by CT imaging
  • Pathologic confirmation of squamous cell carcinoma by biopsy or cytology
  • Signed study-specific consent form
  • Sequential or concurrent chemotherapy is allowed but not mandated. (no chemotherapy is allowed if patient is judged not to be a candidate for chemotherapy by the medical oncologist)

Exclusion Criteria

  • Age < 18
  • Karnofsky Performance Status < 60
  • Radiographic or pathologic evidence of distant metastatic disease (i.e. other than cervical lymph nodes)
  • Prior radiation therapy to the head-and-neck region

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IMRT
External beam radiation with 6 MV photons will be delivered in 200 cGy daily fractions, 35 fractions over 7 weeks for a total dose of 7000 cGy.
Radiation: IMRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of adaptive radiation therapy in the definitive treatment (MLC-based IMRT or helical tomotherapy)
Time Frame: 7 weeks
Feasibility is determined by employing weekly 3D onboard imaging for plan re-evaluation and initiation of an adaptive process if the original PTV and/or normal structure goals are compromised.
7 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure additional time required by physician and ancillary staff for the process of adaptive IMRT
Time Frame: 7 weeks
Recording on a weekly basis the actual time required for repeat CT imaging, plan re-evaluation, replanning, and repeat physics QA.
7 weeks
Identify a subset of patients in whom adaptive IMRT would be recommended
Time Frame: 7 weeks
7 weeks
Measure acute and late toxicity
Time Frame: Until patient death
Until patient death
Local, regional, and distant recurrence
Time Frame: Until recurrence
Until recurrence

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Wade Thorstad, MD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

January 2, 2008

First Submitted That Met QC Criteria

January 22, 2008

First Posted (Estimate)

February 6, 2008

Study Record Updates

Last Update Posted (Estimate)

May 24, 2013

Last Update Submitted That Met QC Criteria

May 22, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-1210

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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