Ovarian-Sparing Adaptive Radiotherapy in Young Adult Women

Recruiting

• Conditions: Uterine Cancer; Sarcoma; Cervix Cancer; Head and Neck Cancer; Anal Cancer; Liver Cancer; Gastric Cancer; Rectal Cancer; Lung Cancer; Colon Cancer

• Registration Number: NCT06904365
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-24
• Study First Submitted QC: 2025-03-24
• Status Verified: 2025-04
• Study First Posted: 2025-04-01
• Study Start: 2025-04-08
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-10
• Primary Completion: 2026-04-15
• Study Completion: 2026-04-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 10

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of ovarian visualization	Estimated to be 5 days	Defined as being able to delineate at least one ovary (if only one is visible, must be the same ovary) for ≥60% of CBCT sessions per patient.

Secondary Outcome Measures

Name	Time	Method
Incidence of dosimetrically sparing one or both ovaries from a functionally ablative radiation dose	Estimated to be 5 days	Defined as maintaining a cumulative \>95% coverage of planned tumor volume (PTV) with 95% of the prescription dose (25 Gy/5 fx) while delivering no more 6 Gy to the ovaries per patient. If only one ovary can meet constraints it must be the same ovary over all fractions.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States