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

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.

• Authors: Marie Plante, Nienke van Trommel, Stephanie Lheureux, Amit M Oza, Lisa Wang, Karolina Sikorska, Sarah Elizabeth Ferguson, Kathy Han, Frederic Amant
• Journal: International journal of gynecological cancer : official journal of the International Gynecological Cancer Society (Int J Gynecol Cancer) Vol. 29 Issue 5 Pg. 969-975 (06 2019) ISSN: 1525-1438 [Electronic] England
• PMID: 31101688 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: © IGCS and ESGO 2019. No commercial re-use. See rights and permissions. Published by BMJ.

Chemical References

• Organoplatinum Compounds
• Paclitaxel

Topics

• Adult
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Chemotherapy, Adjuvant
• Clinical Trial Protocols as Topic
• Feasibility Studies
• Female
• Fertility Preservation (methods)
• Humans
• Neoadjuvant Therapy
• Organoplatinum Compounds (administration & dosage)
• Paclitaxel (administration & dosage)
• Premenopause
• Uterine Cervical Neoplasms (drug therapy, surgery)
• Young Adult