Gynecologic Cancer Clinical Trial
Official title:
Optimizing Brachytherapy Application and Delivery With MRI Guidance for Gynecologic Cancer
Verified date | July 2023 |
Source | Dana-Farber Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to develop new tools using magnetic resonance imaging (MRI) that will improve the brachytherapy procedure and treatment for participants with gynecologic cancer.
Status | Active, not recruiting |
Enrollment | 49 |
Est. completion date | September 15, 2027 |
Est. primary completion date | September 15, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Ability to understand and the willingness to sign a written informed consent document. Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up. - Participants must have a biopsy-proven diagnosis of primary or recurrent gynecologic cancer for which intracavitary or interstitial brachytherapy is planned as standard treatment. Eligible disease sites include primary or recurrent cancer of endometrial, ovarian, cervical, vaginal, or vulvar origin. - Age of 18 years or older are eligible. - ECOG performance status of 2 or less. - Patients who have received prior radiation or chemotherapy may be enrolled on this study. - Participant is deemed to be an appropriate candidate for MRI-guided brachytherapy by the radiation oncologist and the patient elects to be treated with MRI-guided brachytherapy. - Participant provides informed consent for prospective collection of relevant medical records for analysis of clinical outcome and treatment-planning techniques. Exclusion Criteria: - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension, interstitial lung disease, active peptic ulcer disease or gastritis, active bleeding diatheses, serious chronic gastrointestinal conditions associated with diarrhea or psychiatric illness/social situations that would limit compliance with study requirements. - Contraindication to MRI identified by the MR procedure screening form, such as a pacemaker, aneurysm clip, inner ear implant, neurostimulator, or other non-MR compatible implant or device. |
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Dana-Farber Cancer Institute | Brigham and Women's Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Brachytherapy treatment parameters, including V150 | Comparison of brachytherapy treatment parameters for patients treated with or without use of an MR-tracker. V150 is the tumor volume that receives at least 150% of the prescribed radiation dose and is a measure of radiation dose heterogeneity | 3 weeks | |
Secondary | Local-Failure-Free Survival | Time from diagnosis or recurrence to time of local failure | Baseline to 2 years, 5 years | |
Secondary | Progression Free Survival | Time from diagnosis or recurrence to time of documented progression or death | Baseline to 2 years, 5 years | |
Secondary | Overall Survival | Time from diagnosis or recurrence to time of death | Baseline to 2 years, 5 years |
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