Optimized Magnetic Resonance Brachytherapy (MR BT) in Cervix Cancer
Primary Purpose
Cervix Cancer
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
optimised magnetic resonance image-guided intra-uterine brachytherapy
Sponsored by
About this trial
This is an interventional treatment trial for Cervix Cancer focused on measuring Intra-uterine Brachytherapy, cervix cancer, Patients suitable for intra-uterine brachytherapy for invasive carcinoma of the cervix.
Eligibility Criteria
Inclusion Criteria:
- Age over 18 years
- ECOG performance status 0-2
- Histological confirmed carcinoma cervix
- Decision to treat with EBRT (+/- concurrent chemotherapy), and PDR BT
- Ability to comply with study protocol
- Patient informed consent
Exclusion Criteria:
- Unable to or unwilling to give informed consent
- Not suitable for intra-uterine brachytherapy
- Previous treatment for pelvic malignancy
- Previous pelvic radiotherapy
- Serious claustrophobia
- Previous history of metallic injury to the eye
- Non-removable implants contraindicated for MRI
- Cardiac pacemaker
- Other contraindication to MRI -Pregnancy, lactation or child-bearing potential without adequate contraception -
Sites / Locations
- University Health Network
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
(MR BT) in Cervix Cancer
Arm Description
Outcomes
Primary Outcome Measures
Feasibility of clinical implementation of an effective and safe protocol for optimised MR image guided intra-uterine brachytherapy for cervix cancer.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00938106
First Posted
July 10, 2009
Last Updated
October 18, 2022
Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada
1. Study Identification
Unique Protocol Identification Number
NCT00938106
Brief Title
Optimized Magnetic Resonance Brachytherapy (MR BT) in Cervix Cancer
Official Title
Implementation of Optimized Magnetic Resonance Image-guided Intra-uterine Brachytherapy in Cervical Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervix Cancer
Keywords
Intra-uterine Brachytherapy, cervix cancer, Patients suitable for intra-uterine brachytherapy for invasive carcinoma of the cervix.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
(MR BT) in Cervix Cancer
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
optimised magnetic resonance image-guided intra-uterine brachytherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age over 18 years
ECOG performance status 0-2
Histological confirmed carcinoma cervix
Decision to treat with EBRT (+/- concurrent chemotherapy), and PDR BT
Ability to comply with study protocol
Patient informed consent
Exclusion Criteria:
Unable to or unwilling to give informed consent
Not suitable for intra-uterine brachytherapy
Previous treatment for pelvic malignancy
Previous pelvic radiotherapy
Serious claustrophobia
Previous history of metallic injury to the eye
Non-removable implants contraindicated for MRI
Cardiac pacemaker
Other contraindication to MRI -Pregnancy, lactation or child-bearing potential without adequate contraception -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Milosevic, MD
Organizational Affiliation
University Health Network, Princess Margaret Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
12. IPD Sharing Statement
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Optimized Magnetic Resonance Brachytherapy (MR BT) in Cervix Cancer
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