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NCT03785288RECRUITINGIRB Ready

Vaginal Cuff Brachytherapy Fractionation Study

Sponsored by Kara Romano, MD

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
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1 of 258 participants interested
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Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

The purpose of this study is to see the effects of two different standard of care treatments of endometrial cancer on sexual dysfunction. This study will compare two standard of care treatments: HDR (high dose radiation) vaginal brachytherapy 3 fractions of 7 Gy to HDR vaginal brachytherapy 6 fractions of 4Gy for early stage endometrial cancer.

Who Can Participate

Inclusion Criteria

Willingness and ability to provide written informed consent and to comply with the study protocol as judged by the investigator.
Surgery consisted of Total Abdominal or Laparoscopic Hysterectomy and Bilateral Salpingo Oophorectomy (TH-BSO) with or without lymph node dissection.
Subject must have FIGO Stage I-II (grade 1-3) pathologically proven (histologic) endometrioid cancer, including all subtypes. Serous, clear cell, and carcinosarcoma histologic pathologies are allowed.
Subjects must have no measurable disease after surgery.
ECOG Performance Status of 0-2
Age โ‰ฅ 18 years
Subject must have a life expectancy โ‰ฅ 12 months

Exclusion Criteria

Disease of more advanced stage (FIGO stage III-IV) or disease for which adjuvant external beam radiation therapy or chemotherapy is indicated
Patients with a history of prior pelvic radiation therapy or if additional pelvic radiation therapy is planned
Subjects who have not recovered from side effects of a

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

258 participants

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Gender

FEMALE

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Sponsor

Kara Romano, MD

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Baltimore

Maryland

Location available
View Baltimore location page
RECRUITING

Syracuse

New York

Location available
View Syracuse location page
RECRUITING

Charlottesville

Virginia

Location available
View Charlottesville location page

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Vaginal Cancer Treatment in Baltimore?

Join others in Maryland exploring innovative treatment options through clinical research

Vaginal Cancer Treatment Options in Baltimore, Maryland

If you're searching for Vaginal Cancer treatment in Baltimore, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Baltimore, Syracuse, Charlottesville and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Vaginal Cancer. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Maryland
Now Enrolling
Up to 258 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Vaginal Cancer?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Vaginal Cancer

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Vaginal Cancer Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT03785288. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.