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Brachytherapy

Vaginal Brachytherapy for Endometrial Cancer

Phase 3
Recruiting
Research Sponsored by Timothy Showalter, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Surgery consisted of Total Abdominal or Laparoscopic Hysterectomy and Bilateral Salpingo Oophorectomy (TH-BSO) with or without lymph node dissection
ECOG Performance Status of 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial will compare the sexual side effects of two common treatments for endometrial cancer.

Who is the study for?
This trial is for adults over 18 with early-stage endometrial cancer (Stage I-II) who've had a hysterectomy and possibly lymph node removal. They should be able to follow the study plan, have no remaining measurable disease post-surgery, and an expected lifespan of at least one year. It's not for those with prior pelvic radiation, current investigational drug use, uncontrolled medical issues, or advanced stage cancer needing further therapy.Check my eligibility
What is being tested?
The study compares two standard treatments for sexual dysfunction after endometrial cancer: one group receives high dose radiation vaginal brachytherapy in three sessions (7 Gy each), while another gets six sessions (4 Gy each). The goal is to determine which treatment approach is more effective.See study design
What are the potential side effects?
Potential side effects from HDR vaginal brachytherapy may include localized pain or discomfort, skin irritation around the treated area, fatigue, bladder symptoms like increased frequency or urgency of urination and bowel changes such as diarrhea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had surgery to remove my uterus, ovaries, and fallopian tubes.
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I can take care of myself and am up and about more than half of the day.
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I have no signs of cancer after surgery.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Female Sexual Function Index (FSFI)
Preference Option Randomized Design (PORD)
Secondary outcome measures
Vaginal Length Measurement

Trial Design

4Treatment groups
Active Control
Group I: ARM BA: 3 treatments of 7GyActive Control1 Intervention
initially randomized to ARM B but wanted to switch to ARM A of HDR vaginal brachytherapy in 3 treatments (fractions) of 7Gy for a total dose of 21gy
Group II: ARM A: 3 treatments of 7GyActive Control1 Intervention
Arm A: accepted randomization to HDR vaginal brachytherapy in 3 treatments (fractions) of 7Gy for a total dose of 21gy
Group III: ARM B: 6 treatment of 4GyActive Control1 Intervention
Arm B: accepted randomization to HDR vaginal brachytherapy 6 treatments (fractions) of 4Gy for a total does of 24gy
Group IV: ARM AB: 6 treatment of 4GyActive Control1 Intervention
Arm AB: initially randomized to ARM A but wanted to switch to ARM B treatment of HDR vaginal brachytherapy 6 treatments (fractions) of 4Gy for a total does of 24gy

Find a Location

Who is running the clinical trial?

Timothy Showalter, MDLead Sponsor
1 Previous Clinical Trials
32 Total Patients Enrolled
Kara Romano, MDLead Sponsor

Media Library

HDR vaginal brachytherapy (Brachytherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03785288 — Phase 3
Endometrial Cancer Research Study Groups: ARM BA: 3 treatments of 7Gy, ARM A: 3 treatments of 7Gy, ARM B: 6 treatment of 4Gy, ARM AB: 6 treatment of 4Gy
Endometrial Cancer Clinical Trial 2023: HDR vaginal brachytherapy Highlights & Side Effects. Trial Name: NCT03785288 — Phase 3
HDR vaginal brachytherapy (Brachytherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03785288 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would you please provide data regarding the long-term effects of ARM A: 3 treatments of 7Gy?

"This proposed treatment, which would be given to patients 3 times at 7Gy, received a safety score of 3."

Answered by AI

How many individuals are being given this opportunity to participate in this clinical trial?

"Yes, as stated on clinicialtrials.gov, this research is actively recruiting patients. The 258 participants needed for the study are planned to come from 3 different recruitment sites. This trial was first made public on January 17th 2019 with the most recent update being July 6th 2022."

Answered by AI

Are investigators actively seeking participants for this research project?

"That is correct. The online registry shows that this clinical trial is currently recruiting patients. The listing was first created on 17 January 2019 with the most recent update occurring on 6 July 2022. A total of 258 individuals are needed for the study which will take place at 3 different research sites."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Vaginal Cuff Brachytherapy Fractionation Study
Kara Romano, MD 2019. "Vaginal Cuff Brachytherapy Fractionation Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03785288.
~29 spots leftby Jan 2025
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