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.
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
Young Adult
cervical cancer
sln and lympadenectomy
surgical procedures, operative
Journal
International journal of gynecological cancer : official journal of the International Gynecological Cancer Society
ISSN: 1525-1438
Titre abrégé: Int J Gynecol Cancer
Pays: England
ID NLM: 9111626
Informations de publication
Date de publication:
06 2019
06 2019
Historique:
accepted:
08
04
2019
pubmed:
19
5
2019
medline:
6
2
2020
entrez:
19
5
2019
Statut:
ppublish
Résumé
There are limited data regarding the optimal management of pre-menopausal women with cervical lesions measuring 2-4 cm who desire to preserve fertility. To evaluate the feasibility of preserving fertility. Neo-adjuvant chemotherapy will be effective in reducing the size of the tumor and will enable fertility-sparing surgery without compromising oncologic outcome. 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. 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. Assess the rate of functional uterus defined as successful fertility-sparing surgery and no adjuvant therapy. A total of 90 evaluable patients will be needed to complete the study. Expected complete accrual in 2022 with presentation of results by 2025. Pending ethics submission.
Sections du résumé
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.
Identifiants
pubmed: 31101688
pii: ijgc-2019-000398
doi: 10.1136/ijgc-2019-000398
doi:
Substances chimiques
Organoplatinum Compounds
0
Paclitaxel
P88XT4IS4D
Types de publication
Clinical Trial, Phase II
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
969-975Informations de copyright
© IGCS and ESGO 2019. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.