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A Feasibility Study of Adaptive Intensity-Modulated Radiation Therapy (IMRT)
This study has been terminated.
(Lack of accrual and software issues)
Sponsor:
Washington University School of Medicine
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00608751
First received: January 2, 2008
Last updated: May 22, 2013
Last verified: May 2013
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Purpose
Patients with head and neck cancer and are schedule to receive standard radiation therapy known as IMRT to treat cancer
| Condition | Intervention | Phase |
|---|---|---|
| Head and Neck Cancer | Radiation: IMRT | Early Phase 1 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Washington University School of Medicine:
Primary Outcome Measures:
- 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:
- 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.
- Identify a subset of patients in whom adaptive IMRT would be recommended [ Time Frame: 7 weeks ]
- Measure acute and late toxicity [ Time Frame: Until patient death ]
- Local, regional, and distant recurrence [ Time Frame: Until recurrence ]
| Enrollment: | 5 |
| Study Start Date: | January 2007 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
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.
Eligibility| 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00608751
Please refer to this study by its ClinicalTrials.gov identifier: 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
Additional Information:
| Responsible Party: | Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00608751 History of Changes |
| Other Study ID Numbers: |
06-1210 |
| Study First Received: | January 2, 2008 |
| Last Updated: | May 22, 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 |
ClinicalTrials.gov processed this record on August 21, 2017