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
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Radiation: IMRT||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Primary Completion Date :||January 2008|
|Study Completion Date :||January 2008|
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.
- 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.
- 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 ]
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
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Wade Thorstad, MD||Washington University School of Medicine|