A Feasibility Study of Adaptive Intensity-Modulated Radiation Therapy (IMRT)
Patients with head and neck cancer and are schedule to receive standard radiation therapy known as IMRT to treat cancer
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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|
- Feasibility of adaptive radiation therapy in the definitive treatment (MLC-based IMRT or helical tomotherapy) [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Measure acute and late toxicity [ Time Frame: Until patient death ] [ Designated as safety issue: Yes ]
- Local, regional, and distant recurrence [ Time Frame: Until recurrence ] [ Designated as safety issue: No ]
|Study Start Date:||January 2007|
|Study Completion Date:||January 2008|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|