Reduced Planning Target Volume (PTV) Margins for the Treatment of Prostate Cancer Using the Calypso 4D Localization System (PTV)
|ClinicalTrials.gov Identifier: NCT01589939|
Recruitment Status : Unknown
Verified May 2016 by Dusten Macdonald, MD, Madigan Army Medical Center.
Recruitment status was: Active, not recruiting
First Posted : May 2, 2012
Last Update Posted : May 17, 2016
|Condition or disease|
This study will seek to establish the clinical feasibility of a novel real-time localization and tracking system for use of reduced PTV margins during intensity modulated radiation therapy (IMRT), which will allow treatment of smaller volumes of normal tissue during radiation therapy. Such a reduction in the PTV margins and the exposure of healthy tissue during treatment may allow for several future improvements in prostate radiotherapy including:
- decreased acute and chronic adverse effects with similar local tumor control
- dose escalation to achieve higher cure rates with similar adverse effects to standard dose treatment
- hypofractionation to shorten the time of, and lower the expense of, treatment without increased adverse effects.
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Reduced PTV Margins for the Treatment of Prostate Cancer With IMRT Using Real-Time, State-of-the-Art Motion Tracking With the Calypso 4D Localization System: A Feasibility Study|
|Study Start Date :||March 2009|
|Estimated Primary Completion Date :||May 2017|
|Estimated Study Completion Date :||August 2017|
- Radiation therapy with reduced treatment margins can be adopted as feasible for routine clinical use [ Time Frame: Approximately 8.5 weeks (43 fractions per pt.) ]During each radiation treatment fraction, therapists will record set up time, treatment time, total time and number of treatment interventions (repositioning/pausing) as well as the duration of the intervention caused by organ/target motion beyond planning target volume (PTV) margin using real time localization and tracking.
- Analyze dosimetric characteristics of treatment planning [ Time Frame: usually within the first 2 weeks after beacon placement (done at simulation CT) ]
Standard methods vs. reduced planning target volume expansions will be analyzed:
- Dose Volume Histogram (DVH), bladder and rectum
- Volume receiving 77.4Gy by the prescription dose (V77.4Gy), V70Gy, and V50Gy of bladder and rectum
- Assess incidence of acute bladder and rectal toxicity [ Time Frame: approximately 25 months (assessed prior to beacons are placed and then throughout treatment and follow-up) ]toxicity is based on the RTOG/NCI CTC and EPIC quality of life survey.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01589939
|United States, Washington|
|Madigan Healthcare System|
|Tacoma, Washington, United States, 98431|
|Principal Investigator:||Dusten Macdonald, MD||Department of the Army|