Background: There are limited data regarding the optimal management of pre-menopausal women with cervical lesions measuring 2-4 cm who desire to preserve fertility.
Primary objectives: To evaluate the feasibility of preserving fertility.
Study hypothesis: Neo-adjuvant chemotherapy will be effective in reducing the size of the tumor and will enable fertility-sparing surgery without compromising oncologic outcome.
Trial design: Pre-menopausal women diagnosed with stage International Federation of Gynecology and Obstetrics (FIGO) IB2, 2-4 cm cervical cancer who wish to preserve fertility will receive three cycles of platinum/paclitaxel chemotherapy. Patients with complete/partial response will undergo fertility-sparing surgery. Patients will be followed for 3 years to monitor outcome. Patients with suboptimal response (residual lesion ≥2 cm) will receive definitive radical hysterectomy and/or chemoradiation.
Major eligibility criteria: Patients must have histologically confirmed invasive cervical cancer, 2-4 cm lesion, by clinical examination and magnetic resonance imaging (MRI), negative node, and pre-menopausal (≤40 years old). Following three cycles of neo-adjuvant chemotherapy, patients must achieve a complete/partial response (residual lesion <2 cm). Exclusion criteria include high-risk histology, tumor extension to uterine corpus/isthmus (as per MRI), and suboptimal response/progression following neo-adjuvant chemotherapy.
Primary endpoints: Assess the rate of functional uterus defined as successful fertility-sparing surgery and no adjuvant therapy.
Sample size: A total of 90 evaluable patients will be needed to complete the study.
Estimated dates for completing accrual and presenting results: Expected complete accrual in 2022 with presentation of results by 2025.
Trial registration number: Pending ethics submission.
Keywords: cervical cancer; sln and lympadenectomy; surgical procedures, operative.
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