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Brachytherapy

MRI-Guided Brachytherapy for Gynecologic Cancer

N/A

Waitlist Available

Led By Larissa J Lee, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

ECOG performance status of 2 or less

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 2 years, 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying MRI tools to improve cancer treatment.

Who is the study for?

This trial is for adults over 18 with gynecologic cancers (like cancer of the endometrium, ovaries, cervix, vagina, or vulva) who are suitable and choose to undergo MRI-guided brachytherapy. They must understand the study and agree to follow its procedures. Prior radiation or chemotherapy is okay. However, those with certain medical implants that aren't safe in an MRI machine or have serious illnesses affecting their ability to participate are excluded.

What is being tested?

The study aims to improve brachytherapy for gynecologic cancer using new tools developed with magnetic resonance imaging (MRI). Participants will receive this advanced form of treatment which allows precise targeting of cancerous tissue while sparing healthy areas.

What are the potential side effects?

While specific side effects aren't listed for this trial's interventions, typical risks associated with MRI include discomfort from lying still during the scan. Brachytherapy can cause localized pain, swelling, bleeding or bruising at the treatment site; fatigue; skin irritation; and other tissue-specific side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a confirmed gynecologic cancer and am planning to undergo brachytherapy.

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I can take care of myself but cannot do heavy physical work.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any serious ongoing illnesses that my doctor is still trying to control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 2 years, 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 2 years, 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 2 years, 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Brachytherapy treatment parameters, including V150

Secondary study objectives

Local-Failure-Free Survival

Overall Survival

Progression Free Survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: MRI Guided BRACHYTHERAPY without TrackerExperimental Treatment2 Interventions

* Standard pelvic MRI sequences will be obtained * Standard process is used with serial MR imaging to evaluate catheter position during implant * All patients will undergo 3D-based image acquisition for brachytherapy treatment planning per standard clinical practice * The brachytherapy modality to be used is high-dose-rate brachytherapy using an iridum-192 stepping source

Group II: MRI Guided BRACHYTHERAPY with TrackerExperimental Treatment3 Interventions

* Standard pelvic MRI sequences will be obtained * MRI Tracker is used during catheter positioning with serial MR imaging during implant * All patients will undergo 3D-based image acquisition for brachytherapy treatment planning per standard clinical practice * The brachytherapy modality to be used is high-dose-rate brachytherapy using an iridum-192 stepping source

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MRI

2009

Completed Phase 2

~2810

Brachytherapy

2007

Completed Phase 3

~2140