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Ovarian-Sparing Adaptive Radiotherapy in Young Adult Women

Ovarian-Sparing Adaptive Radiotherapy in Young Adult Women

Recruiting
18-50 years
Female
Phase N/A

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Overview

Female patients with early onset (<50 years old) pelvic malignancies such as uterine and rectal cancers are rising in incidence, which often requires pelvic radiation; many of these patients are premenopausal and at a high risk of premature ovarian failure from radiotherapy. Premature ovarian failure carries significant cardiac, musculoskeletal, sexual, and psychosocial morbidity. Ovarian transposition carries variable success rates, is not readily accessible to the general population, and can still be at risk of clinically significant radiotherapy doses. There is an unmet need for innovative techniques to protect ovarian function.

Eligibility

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

Study details
    Uterine Cancer
    Rectal Cancer
    Colon Cancer
    Breast Cancer
    Lung Cancer
    Sarcoma
    Cervix Cancer
    Head and Neck Cancer
    Anal Cancer
    Liver Cancer
    Gastric Cancer
    Bladder Cancer

NCT06904365

Washington University School of Medicine

15 October 2025

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