Internal Radiation Therapy with or without MRI Guidance in Treating Patients with Gynecologic Cancer

Status: Active

Description

This randomized clinical trial studies how well internal radiation therapy with or without magnetic resonance imaging (MRI) works in treating patients with gynecologic cancer. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Computer systems that allow doctors to create a 3-dimensional (3-D) picture of the tumor may help in planning radiation therapy and may result in more tumor cells being killed. Using a magnetic resonance (MR)-tracking device may improve the placement of the brachytherapy catheters.

Eligibility Criteria

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
  • Eastern Cooperative Oncology Group (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

Locations & Contacts

Massachusetts

Boston
Brigham and Women's Hospital
Status: Active
Contact: Larissa J. Lee
Phone: 617-732-4332
Email: LLEE13@PARTNERS.ORG
Dana-Farber Cancer Institute
Status: Active
Contact: Larissa J. Lee
Phone: 617-732-4332
Email: LLEE13@PARTNERS.ORG

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To compare brachytherapy treatment parameters, specifically V150 (target volume that receives 150% of the prescription dose) as a measure of dose heterogeneity, for patients treated with and without use of the MR-tracker when stratified by template-based versus (vs.) tandem-based interstitial applicators.

SECONDARY OBJECTIVES:

I. Local tumor control following MR-based brachytherapy, defined by radiographic parameters or biopsy on routine follow-up at 2 and 5 years.

II. Documentation of radiographic parameters for correlative outcome study.

III. Clinical outcome including disease-free survival, overall survival and treatment-related toxicity at 2 and 5 years.

IV. Patient-reported quality of life (QOL) assessment at baseline, within 3 weeks before and/or after the brachytherapy procedure, and 1 year post treatment.

OUTLINE: Patients are randomized into 1 of 2 arms.

ARM I: Patients undergo high-dose-rate (HDR) brachytherapy with MR-tracker.

ARM II: Patients undergo HDR brachytherapy without MR-tracker.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 5 years.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Treatment

Lead Organization

Lead Organization
Dana-Farber Harvard Cancer Center

Principal Investigator
Larissa J. Lee

Trial IDs

Primary ID 17-128
Secondary IDs NCI-2017-02335
Clinicaltrials.gov ID NCT03277469