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.
- cervical cancer
- sln and lympadenectomy
- surgical procedures, operative
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Contributors MP, NvT, SL, AM, FA: protocol development. MP, NvT, SL: manuscript writing. SF: QoL studies. KH: correlative studies. LW, KS: statistics.
Funding The Princess Margaret Consortium is responsible for the funding of the Canadian sites’ accrual and for the overall data management. Each cooperative group is responsible for its own funding.
Competing interests None declared.
Patient consent for publication Not required.
Provenance and peer review Commissioned; internally peer reviewed.
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