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

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ClinicalTrials.gov Identifier: NCT00608751
Recruitment Status : Terminated (Lack of accrual and software issues)
First Posted : February 6, 2008
Last Update Posted : May 24, 2013
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Description
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Brief Summary:
Patients with head and neck cancer and are schedule to receive standard radiation therapy known as IMRT to treat cancer

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Radiation: IMRT Early Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Feasibility Study of Adaptive Intensity-Modulated Radiation Therapy in the Definitive Treatment of Head-and-Neck Cancer
Study Start Date : January 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

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U.S. FDA Resources

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Identify a subset of patients in whom adaptive IMRT would be recommended [ Time Frame: 7 weeks ]
  3. Measure acute and late toxicity [ Time Frame: Until patient death ]
  4. Local, regional, and distant recurrence [ Time Frame: Until recurrence ]

Eligibility Criteria
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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:

  • 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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00608751


Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Wade Thorstad, MD Washington University School of Medicine
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine  This link exits the ClinicalTrials.gov site

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00608751     History of Changes
Other Study ID Numbers: 06-1210
First Posted: February 6, 2008    Key Record Dates
Last Update Posted: May 24, 2013
Last Verified: May 2013

Keywords provided by Washington University School of Medicine:
Newly Diagnosed head and neck cancer

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