Clinical trial NCT06904365: Ovarian-Sparing Adaptive Radiotherapy in Young Adult Women
Official title: Ovarian-Sparing Adaptive Radiotherapy in Young Adult Women (OvAR-Y): an In-Silico Feasibility Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: 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
Keywords: Young onset colorectal cancer
Early onset
Pre-menopausal
Ovarian sparing radiation
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Varian Medical Systems
First posted: 2025-04-01
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will enroll patients at Siteman Cancer Center at 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.


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

Primary outcomes:
measure: Incidence of ovarian visualization
timeFrame: Estimated to be 5 days
Secondary outcomes:
measure: Incidence of dosimetrically sparing one or both ovaries from a functionally ablative radiation dose
timeFrame: Estimated to be 5 days
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Hyun Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References: