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| Sponsored by: |
University Health Network, Toronto |
|---|---|
| Information provided by: | University Health Network, Toronto |
| ClinicalTrials.gov Identifier: | NCT00938106 |
Purpose
Patients with cervix cancer usually require external radiation given to the whole pelvis then an internal radiation boost, also called brachytherapy, to treat any remaining tumour. Standard brachytherapy has been used successfully for many years, but does not take into account differences in the shape of the tumour or normal structures between patients. This study aims to implement individualized -optimized- brachytherapy, based on international recommendations. MR scanning with the intra-uterine applicator in place allows improved identification of residual tumour and normal structures, allowing brachytherapy to be individualized for each patient with the aim to reduce side-effects and improve outcome. Additionally, repeating MR scans during brachytherapy treatment will allow further assessment on motion of the applicator during treatment and the effect on radiation dose. Sexual health assessments aim to identify the relationship between sexual health and treatment effects.
| Condition | Intervention | Phase |
|---|---|---|
|
Cervix Cancer |
Radiation: optimised magnetic resonance image-guided intra-uterine brachytherapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Implementation of Optimized Magnetic Resonance Image-guided Intra-uterine Brachytherapy in Cervical Cancer |
| Estimated Enrollment: | 60 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | May 2011 |
| Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Michael Milosevic, MD | 416 946 4501 ext 6522 | michaeal.milosevic@rmp.uhn.on.ca |
| Canada, Ontario | |
| University Health Network | Recruiting |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Contact: Michael Milosevic, MD 416 946 4501 ext 6522 michael.milosevic@rmp.uhn.on.ca | |
| Principal Investigator: | Michael Milosevic, MD | University Health Network, Princess Margaret Hospital |
More Information
| Responsible Party: | University Health Network, Princess Margaret Hospital ( Dr. Michael Milosevic, Staff Radiation Oncologist, Clinician Scientist ) |
| Study ID Numbers: | UHN REB 08-0206-C |
| Study First Received: | July 10, 2009 |
| Last Updated: | July 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00938106 History of Changes |
| Health Authority: | Canada: Ethics Review Committee |
|
Intra-uterine Brachytherapy cervix cancer Patients suitable for intra-uterine brachytherapy for invasive carcinoma of the cervix. |
|
Genital Diseases, Female Uterine Cervical Neoplasms Uterine Cervical Diseases Genital Neoplasms, Female |
Uterine Diseases Uterine Neoplasms Urogenital Neoplasms Carcinoma |
|
Genital Diseases, Female Uterine Cervical Neoplasms Uterine Cervical Diseases Neoplasms Neoplasms by Site |
Genital Neoplasms, Female Uterine Diseases Uterine Neoplasms Urogenital Neoplasms |
