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Int J Gynecol Cancer. 2019 May 17. pii: ijgc-2019-000398. doi: 10.1136/ijgc-2019-000398. [Epub ahead of print]

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.

Author information

1
Obstetrics and Gynecology, Centre Hospitalier Universitaire de Quebec, Quebec City, Quebec, Canada marie.plante@crhdq.ulaval.ca.
2
Gynecologic Oncology, Netherlands Cancer Institute, Amsterdam, Noord-Holland, Netherlands.
3
Gynecologic Oncology, Center for Gynecologic Oncology Amsterdam, Amsterdam, Netherlands.
4
Drug Development Program, Princess Margaret Consortium, Toronto, Ontario, Canada.
5
Department of Medicine, Princess Margaret Hospital Cancer Centre, Toronto, Ontario, Canada.
6
Department of Biostatistics, Netherlands Cancer Institute, Amsterdam, Noord-Holland, Netherlands.
7
Gynecologic Oncology, Princess Margaret Hospital Cancer Centre, Toronto, Ontario, Canada.
8
Princess Margaret Hospital Cancer Centre, Toronto, Ontario, Canada.
9
Netherlands Cancer Institute, Amsterdam, Noord-Holland, Netherlands.
10
Gynecologic Oncology, Amsterdam University Medical Centers, Amsterdam, Netherlands.

Abstract

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

PMID:
31101688
DOI:
10.1136/ijgc-2019-000398

Conflict of interest statement

Competing interests: None declared.

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