Optimized Magnetic Resonance Brachytherapy (MR BT) in Cervix Cancer
|Cervix Cancer||Radiation: optimised magnetic resonance image-guided intra-uterine brachytherapy||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Implementation of Optimized Magnetic Resonance Image-guided Intra-uterine Brachytherapy in Cervical Cancer|
- Feasibility of clinical implementation of an effective and safe protocol for optimised MR image guided intra-uterine brachytherapy for cervix cancer. [ Time Frame: 36 months ]
- Determine local control,overall survival,acute & late toxicity, & sexual health of patients treated with optimised intra-uterine BT. Evaluate stability of the intra-uterine applicator during BT. Evaluate dose homogeneity of BT for cervix cancer. [ Time Frame: 36 months ]
|Study Start Date:||May 2008|
|Estimated Study Completion Date:||May 2017|
|Estimated Primary Completion Date:||May 2017 (Final data collection date for primary outcome measure)|
|Experimental: (MR BT) in Cervix Cancer||
Radiation: optimised magnetic resonance image-guided intra-uterine brachytherapy
Brachytherapy treatment will be planned based on the MRI test and will be individualized for each study participant,based on participant's cancer and body inside.Brachytherapy will be as an inpatient over 2-3 days. All other care will follow standard procedures.
Pre-treatment: Prior to examination under anaesthesia and placement of the intra-uterine applicator, in addition to standard assessment of treatment toxicity, the patient may complete an optional Sexual Health assessment taking approximately 15 minutes. Following standard insertion of the intra-uterine applicator under general anaesthetic and planning MRI scan, there is an optional additional MRI scan taking an extra 30 minutes This extra scan will not affect the commencement of treatment planning as images from the planning scan will be transferred to the treatment planning system as soon as they are obtained. From the MRi planning scan, target and specific normal structures are contoured. An individual BT plan will be derived based on a standard plan to deliver dose within specified dose volume constraints.
During treatment: During inpatient BT optional MRI scans, each taking 15 minutes will be obtained in the period between treatment pulses once during each 24 hours of admission. The information from the additional MRI scans will not be used to alter or influence treatment.
Follow-up: Standard follow-up procedures will be followed, with the optional addition of the Sexual Health evaluation at each visit.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00938106
|University Health Network|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Michael Milosevic, MD||University Health Network, Princess Margaret Hospital|