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Utero-ovarian Transposition in Patients With Pelvic Malignancies Undergoing Whole Pelvic Radiotherapy
NCT07419490 · University of South Florida
In plain English
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Official title
A Phase I Assessment of Utero-ovarian Transposition (UOT) for Fertility Preservation in Patients With Pelvic Malignancies Undergoing Whole Pelvic Radiotherapy (WPXRT)
About this study
This is a phase I study aimed to evaluate feasibility and safety of utero-ovarian transposition (UOT) in young women undergoing whole pelvic radiation therapy (WPXRT) for treatment of a colorectal or other cancers localized to the pelvis. By comprehensively evaluating real-world outcomes for women undergoing this procedure, the proposed work will lay the groundwork necessary to establish UOT as a viable option for fertility preservation and survivorship for this unique patient population. Rigorous inclusion and exclusion criteria will ensure the selection of appropriate candidates, who will undergo a minimally invasive transposition of their cervix, uterus, tube and ovaries outside the planned radiation fields, thus sparing transposed organs from radiation exposure. Following a brief recovery, the radiation oncology team will proceed with WPXRT to treat each patient's cancer. If chemotherapy is indicated, it will be completed at this time, prior to the second procedure. After completing radiation therapy and/or chemotherapy, the uterus and adnexa will be surgically returned to their normal anatomical position.
This study will assess surgical outcomes for enrolled subjects undergoing this care plan, assess quality of life and the preservation of fertility and uterine receptivity by multiple objective measures.
Throughout the study, patients will be closely monitored for perioperative outcomes, including surgical complications, hospital stay, and quality of life. Patterns of menstruation, as well as levels of key hormones routinely used to assess fertility (FSH, LH, AMH, and estradiol) will be measured at key time points.
Successful UOT will be defined as the ability to complete the procedure and successfully restore a viable uterus and adnexa capable of supporting normal menstruation and fertility post-radiation therapy.
The resumption of menstrual cycles for six months following the procedure will be evaluated. Quality of life will be evaluated at multiple steps as women undergo the proposed procedures as well as throughout the planned 6 months follow up window.
Data generated by this pilot study will provide critical insights into the feasibility, safety, and potential benefits of UOT as a fertility-preserving and ovarian function-conserving option for patients with pelvic malignancies undergoing WPXRT. Moving forward, data from this study will be used not only to build out the programmatic and clinical infrastructure needed to further evaluate the efficacy of UOT, but also to overcome roadblocks to its successful clinical implementation in the future.
Eligibility criteria
Inclusion Criteria:
1. Age: Women 18 - 40 years of age who wish to preserve their fertility.
2. Malignancy: Diagnosis of pelvic malignancies that require radiotherapy, including:
1. Colon and rectal cancer with tumors.
2. Anal cancer.
3. Other pelvic malignancies that require administration of WPXRT.
3. Desire for Fertility Preservation: The patient expresses a clear desire to preserve fertility and the ability to carry a pregnancy in the future.
4. Preoperative Ovarian Function: The patient must have normal ovarian function, demonstrated by specific hormonal values, including:
1. Follicle-Stimulating Hormone (FSH): \<10 IU/L
2. Luteinizing Hormone (LH): within normal reference range for reproductive age (typically 1.5-8 IU/L in the early follicular phase).
3. Anti-Müllerian Hormone (AMH): \>1 ng/mL
4. Estradiol (E2): within the normal range for the follicular phase (usually 30-120 pg/mL).
5. No Distant Metastasis: Absence of metastatic disease confirmed by imaging (CT, MRI, or PET scans).
6. Body Mass Index (BMI) \< 35.
7. Signed Informed Consent.
Exclusion Criteria:
1. Advanced Cancer Stage: Patients with locally advanced or metastatic disease.
2. Significant Uterine Pathology: Presence of large uterine fibroids, adenomyosis, or other intrauterine pathologies that would complicate the procedure or future pregnancy.
3. Poor General Health or Comorbidities: Severe medical conditions that contraindicate surgical intervention, that include but not limited to:
* Cardiovascular Disease:
1. Recent (within 6 months) myocardial infarction (MI).
2. Ejection fraction (EF): EF \<30%.
3. Uncontrolled hypertension: Systolic BP \>180 mmHg or Diastolic BP \>110 mmHg prior to surgery.
4. Severe aortic stenosis: Valve area \<1 cm² with symptomatic status.
* Uncontrolled Diabetes Mellitus:
1. Hemoglobin A1c (HbA1c) \> 9%
2. Persistent fasting glucose \>250 mg/dL preoperatively despite optimization.
* Severe Respiratory Diseases:
1. Forced expiratory volume (FEV1): \<50%.
2. Oxygen saturation: Resting SpO₂ \<88% on room air without supplemental oxygen.
3. CO2 retention: PaCO₂ \>50 mmHg.
* Connective Tissue Disorders:
1. Severe systemic lupus erythematosus (SLE): Active lupus nephritis with GFR \<30 mL/min.
2. Scleroderma with severe pulmonary hypertension or FVC \<50% predicted.
3. Rheumatoid arthritis with severe cervical spine instability (atlantoaxial subluxation).
* Severe Inflammatory Bowel Disease (IBD):
1. Severe Crohn's or ulcerative colitis flares with C-reactive protein (CRP) \>10 mg/L and hypoalbuminemia (Albumin \<2.5 g/dL).
2. Severe malnutrition: BMI \<18.5 kg/m² or Prealbumin \<10 mg/dL
* Steroid dependency:
1. Chronic steroid use (\>20 mg prednisone daily) with no feasible taper pre-surgery.
4. Prior Pelvic Radiotherapy.
5. Prior history of systemic chemotherapy and immunotherapy that resulted in significant toxicity and residual deficit.
6. Pregnancy: Patients who are currently pregnant are excluded from consideration for uterine transposition.
7. Unsuitable for Ovarian Function Preservation: Women with signs of poor ovarian reserve, including:
* FSH: \>10 IU/L
* AMH: \<1 ng/mL
* Estradiol: outside normal range.
8. Non-Candidate for Fertility: Patients with contraindications to future pregnancy, such as severe uterine abnormalities or significant risk for pregnancy-related complications.
9. Body Mass Index (BMI) ≥35.
10. Absence of One of the Gonadal Vessels.
11. Other unlisted conditions or diagnoses that, in the opinion of the primary investigator, render the patient an unsuitable candidate for uteroovarian transposition.
Study design
Enrollment target: 26 participants
Allocation: na
Masking: none
Age groups: child
Timeline
Starts: 2026-04-01
Estimated completion: 2031-06
Last updated: 2026-06-24
Interventions
Procedure: Uteroovarian transposition
Primary outcomes
- • Success of uterine transposition (From enrollment to completion of surveillance/monitoring at 52 weeks)
Sponsor
University of South Florida · other
Contacts & investigators
ContactBrittani Powell, MPH, CCRP · contact · RSCH-IRB@usf.edu · (813) 974-5638
ContactJennifer Childress, RN, CCRP · contact · jchildress@tgh.org · 813-844-1053
InvestigatorVaagn Andikyan · principal_investigator, USF Health Morsani College of Medicine
All locations (1)
Tampa General HospitalRecruiting
Tampa, Florida, United States