FIGO 2018 stage IB2 (2–4 cm) Cervical cancer treated with Neo-adjuvant chemotherapy followed by fertility Sparing Surgery (CONTESSA); Neo-Adjuvant Chemotherapy and Conservative Surgery in Cervical Cancer to Preserve Fertility (NEOCON-F). A PMHC, DGOG, GCIG/CCRN and multicenter study

Abstract

BackgroundThere are limited data regarding the optimal management of pre-menopausal women with cervical lesions measuring 2–4 cm who desire to preserve fertility.Primary objectivesTo evaluate the feasibility of preserving fertility.Study hypothesisNeo-adjuvant chemotherapy will be effective in reducing the size of the tumor and will enable fertility-sparing surgery without compromising oncologic outcome.Trial designPre-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 criteriaPatients 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 endpointsAssess the rate of functional uterus defined as successful fertility-sparing surgery and no adjuvant therapy.Sample sizeA total of 90 evaluable patients will be needed to complete the study.Estimated dates for completing accrual and presenting resultsExpected complete accrual in 2022 with presentation of results by 2025.Trial registration numberPending ethics submission.