Ovarian-Sparing Adaptive Radiotherapy in Young Adult Women

Launched by WASHINGTON UNIVERSITY SCHOOL OF MEDICINE · Mar 24, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to protect the ovaries of young women who need radiation therapy for certain cancers, such as uterine or rectal cancer. Many women under 50 are facing these cancers, and the radiation treatment can sometimes lead to early menopause, which can cause a range of health issues. The goal of this study is to find innovative techniques to help preserve ovarian function, so women can maintain their hormonal balance and overall health after treatment.

To participate in the trial, women must be between 18 and 50 years old, biologically female, and currently experiencing regular menstrual cycles. They should also be planning to receive radiation therapy for their cancer. Participants will need to be able to understand the study and provide consent to take part. If someone has had previous pelvic radiation, certain cancer treatments, or is showing signs of menopause, they may not be eligible. Throughout the trial, participants will receive detailed information and support regarding what to expect, helping them navigate this important journey in their health care.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Biologic female
• • Age between 18 and 50 years old (inclusive)
• • Clinically premenopausal (defined as having active, regular menstruation without vasomotor symptoms)
• • At least one of two ovaries readily visualized on diagnostic CT or MR imaging as confirmed by radiologist
• • Planning to receive radiation therapy (for any indication)
• • Ability to understand and willingness to sign an IRB-approved written informed consent document.
• Exclusion Criteria:
• • Prior pelvic radiation
• • Prior cancer therapies that are known to impact ovarian function
• • Prior diagnosis of ovarian insufficiency/failure or menopause
• • Clinically peri- or post-menopausal
• • For patients \> 45 years old, if there is a clinical history of vasomotor symptoms OR irregular periods, then the patient must be excluded.
• • For patients ≤ 45 years old, if there is a history of vasomotor symptoms consistent with menopause OR irregular menstruation for ≥3 months OR recent changes in their menstrual cycle \> 14 days, then the patient must be excluded.
• • Surgically removed or transposed ovaries
• • Pregnant and/or breastfeeding