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P09 FIGO 2018 stage IB2 (≥2 to <4 cm) cervical cancer treated with neoadjuvant chemotherapy followed by fertility sparing surgery (CoNteSSa)/Neoadjuvant chemotherapy and conservative surgery in cervical cancer to preserve fertility (NeoCon-F)
  1. M Plante1,
  2. N van Trommel2,
  3. S Lheureux3,
  4. A Oza3,
  5. L Wang3,
  6. K Sikorska4,
  7. S Ferguson5,
  8. K Han6 and
  9. F Amant7,8,9
  1. 1Division of Gynecologic Oncology, Laval University – Centre Hospitalier Universitaire de Québec – L’Hôtel-Dieu de Québec, Quebec, QC, Canada
  2. 2Gynecologic Oncology, Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands
  3. 3Drug Development Program, Princess Margaret Consortium, Toronto, ON, Canada
  4. 4Department of Biostatistics, The Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands
  5. 5Department of Obstetrics and Gynecology
  6. 6Radiation Medicine Program – Department of Radiation Oncology, Princess Margaret Cancer Center, Toronto, ON, Canada
  7. 7Gynecologic Oncology, Antoni van Leeuwenhoek Hospital – The Netherlands Cancer Institute
  8. 8Gynaecologic Oncology, Department Woman and Child, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands
  9. 9Gynecologic Oncology, KU Leuven – University of Leuven, University Hospitals Leuven, Leuven, Belgium


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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