Utero-ovarian Transposition in Patients With Pelvic Malignancies Undergoing Whole Pelvic Radiotherapy

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.