Cervix CancerPhase 2NCT00938106
Optimized Magnetic Resonance Brachytherapy (MR BT) in Cervix Cancer
A Phase 2 study testing optimised magnetic resonance image-guided intra-uterine brachytherapy in people with Cervix Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervix Cancer
- What is being tested?
- optimised magnetic resonance image-guided intra-uterine brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- May 2008to Jan 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Non-removable implants contraindicated for MRI
- Cardiac pacemaker
- Other contraindication to MRI -Pregnancy, lactation or child-bearing potential without adequate contraception -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation of Optimized Magnetic Resonance Image-guided Intra-uterine Brachytherapy in Cervical Cancer
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.
Read the 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.
- Conditions
- Cervix Cancer
- Being tested
- optimised magnetic resonance image-guided intra-uterine brachytherapy
- Keywords
- Intra-uterine Brachytherapy, cervix cancer, Patients suitable for intra-uterine brachytherapy for invasive carcinoma of the cervix.
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
optimised magnetic resonance image-guided intra-uterine brachytherapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| (MR BT) in Cervix Cancer | Experimental | Not described Receives: Radiation: optimised magnetic resonance image-guided intra-uterine brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of clinical implementation of an effective and safe protocol for optimised MR image guided intra-uterine brachytherapy for cervix cancer.
Measured: 36 months
Secondary outcomes (1)
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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2009 (estimated)
- Study startMay 2008
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervix CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Responsible party
- Sponsor
- Investigators
- Michael Milosevic, MD, Principal investigator, University Health Network, Princess Margaret Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00938106
- Sponsor's protocol ID
- UHN REB 08-0206-C
- Status last verified
- Oct 2022
- First submitted
- 10 Jul 2009
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Optimized Magnetic Resonance Image-guided Intra-uterine Brachytherapy in Cervical Cancer
- ClinicalTrials.gov ID
- NCT00938106
- Acronym / sponsor ID
- UHN REB 08-0206-C
- Conditions
- Cervix Cancer
- Keywords
- Intra-uterine Brachytherapy, cervix cancer, Patients suitable for intra-uterine brachytherapy for invasive carcinoma of the cervix.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Study start
- May 2008
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 13 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| (MR BT) in Cervix Cancer | Experimental | Radiation: optimised magnetic resonance image-guided intra-uterine brachytherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- Unable to or unwilling to give informed consent
- Not suitable for intra-uterine brachytherapy
- Previous treatment for pelvic malignancy
- Previous pelvic radiotherapy
- Serious claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| optimised magnetic resonance image-guided intra-uterine brachytherapyBrachytherapy 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. | Radiation | (MR BT) in Cervix Cancer |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
Related trials for Cervix Cancer
Active, not recruitingObservational study
Vaginal Microbiome and HPV Pre-malignant and Cervical Dysplasia
Human Papilloma Virus, Vaginal Flora Imbalance
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
International PPB/DICER1 Registry
Pleuropulmonary Blastoma, Sertoli-Leydig Cell Tumor
Active, not recruitingPhase 2
Intratreatment FDG-PET During Radiation Therapy for Gynecologic and Gastrointestinal Cancers
Cancer of the Cervix, Vulvar Cancer
Active, not recruiting
Physical Activity Intervention Among Older Women With Gynecologic Cancers (Fit4Treatment)
Ovary Cancer, Endometrial Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Milosevic, MD principal investigator
University Health Network, Princess Margaret Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing optimised magnetic resonance image-guided intra-uterine brachytherapy in people with Cervix Cancer, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2022; AzTrials last refreshed its copy on 7 Nov 2026.