Introduction/Background There is limited data regarding the optimal management of premenopausal women with cervical lesions measuring ≥2 to<4 cm who desire to preserve fertility.
Methodology Study hypothesis: Neoadjuvant chemotherapy (NACT) will be effective in reducing the size of the tumor and will enable fertility-sparing surgery (FSS) without compromising oncologic outcome.
Primary objective: To evaluate the feasibility of preserving fertility.
Secondary objectives: To evaluate response rate to NACT, surgical complications and rate of FSS, overall survival up to 3 years for patients who completed NACT and FSS.
Trial design: Premenopausal women diagnosed with stage IB2, ≥2 to <4 cm cervical cancer who wish to preserve fertility will receive 3 cycles of platinum/paclitaxel chemotherapy. Patients with complete/partial response (residual lesion <2 cm) will undergo FSS. 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 to <4 cm lesion by clinical evaluation and MRI, negative nodes and premenopausal (≤40 years old). Following 3 cycles of NACT, patients must achieve a complete/partial response. Exclusion criteria include high-risk histology, tumor extension to uterine corpus/isthmus (as per MRI) and suboptimal response/progression following NACT.
Results Primary endpoints: Assess the rate of functional uterus defined as successful FSS and no adjuvant therapy.
Exploratory objectives: Evaluate patients reported outcome and quality of life, ovarian function and rate of pregnancy during follow-up period (3 years). Translational research part is included.
Conclusion This is a Phase II, prospective international trial. 90 evaluable patients will be needed to complete the study. A stopping rule will be activated if the recurrence rate at 2 years exceeds 10%. Activation is planned for the summer 2019.
Disclosure Nothing to disclose.
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