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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
by
Wang, Lisa
, Amant, Frederic
, Han, Kathy
, Oza, Amit M
, Plante, Marie
, Ferguson, Sarah Elizabeth
, Lheureux, Stephanie
, Sikorska, Karolina
, van Trommel, Nienke
in
Abdomen
/ Adult
/ Antineoplastic Combined Chemotherapy Protocols - therapeutic use
/ Cancer therapies
/ Cervical cancer
/ Chemotherapy
/ Chemotherapy, Adjuvant
/ Clinical Trial Protocols as Topic
/ Data analysis
/ Feasibility Studies
/ Female
/ Fertility
/ Fertility Preservation - methods
/ Gynecology
/ Histology
/ Humans
/ Hysterectomy
/ Infertility
/ Lymphatic system
/ Medical prognosis
/ Neoadjuvant Therapy
/ Obstetrics
/ Organoplatinum Compounds - administration & dosage
/ Paclitaxel - administration & dosage
/ Premature labor
/ Premenopause
/ Quality of life
/ Radiation therapy
/ Response rates
/ sln and lympadenectomy
/ Surgery
/ surgical procedures, operative
/ Uterine Cervical Neoplasms - drug therapy
/ Uterine Cervical Neoplasms - surgery
/ Womens health
/ Young Adult
2019
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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
by
Wang, Lisa
, Amant, Frederic
, Han, Kathy
, Oza, Amit M
, Plante, Marie
, Ferguson, Sarah Elizabeth
, Lheureux, Stephanie
, Sikorska, Karolina
, van Trommel, Nienke
in
Abdomen
/ Adult
/ Antineoplastic Combined Chemotherapy Protocols - therapeutic use
/ Cancer therapies
/ Cervical cancer
/ Chemotherapy
/ Chemotherapy, Adjuvant
/ Clinical Trial Protocols as Topic
/ Data analysis
/ Feasibility Studies
/ Female
/ Fertility
/ Fertility Preservation - methods
/ Gynecology
/ Histology
/ Humans
/ Hysterectomy
/ Infertility
/ Lymphatic system
/ Medical prognosis
/ Neoadjuvant Therapy
/ Obstetrics
/ Organoplatinum Compounds - administration & dosage
/ Paclitaxel - administration & dosage
/ Premature labor
/ Premenopause
/ Quality of life
/ Radiation therapy
/ Response rates
/ sln and lympadenectomy
/ Surgery
/ surgical procedures, operative
/ Uterine Cervical Neoplasms - drug therapy
/ Uterine Cervical Neoplasms - surgery
/ Womens health
/ Young Adult
2019
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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
by
Wang, Lisa
, Amant, Frederic
, Han, Kathy
, Oza, Amit M
, Plante, Marie
, Ferguson, Sarah Elizabeth
, Lheureux, Stephanie
, Sikorska, Karolina
, van Trommel, Nienke
in
Abdomen
/ Adult
/ Antineoplastic Combined Chemotherapy Protocols - therapeutic use
/ Cancer therapies
/ Cervical cancer
/ Chemotherapy
/ Chemotherapy, Adjuvant
/ Clinical Trial Protocols as Topic
/ Data analysis
/ Feasibility Studies
/ Female
/ Fertility
/ Fertility Preservation - methods
/ Gynecology
/ Histology
/ Humans
/ Hysterectomy
/ Infertility
/ Lymphatic system
/ Medical prognosis
/ Neoadjuvant Therapy
/ Obstetrics
/ Organoplatinum Compounds - administration & dosage
/ Paclitaxel - administration & dosage
/ Premature labor
/ Premenopause
/ Quality of life
/ Radiation therapy
/ Response rates
/ sln and lympadenectomy
/ Surgery
/ surgical procedures, operative
/ Uterine Cervical Neoplasms - drug therapy
/ Uterine Cervical Neoplasms - surgery
/ Womens health
/ Young Adult
2019
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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
Journal Article
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
2019
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Overview
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.
Publisher
Elsevier Inc,by the International Gynecologic Cancer Society and the European Society of Gynaecological Oncology,Elsevier Limited
Subject
/ Adult
/ Antineoplastic Combined Chemotherapy Protocols - therapeutic use
/ Clinical Trial Protocols as Topic
/ Female
/ Fertility Preservation - methods
/ Humans
/ Organoplatinum Compounds - administration & dosage
/ Paclitaxel - administration & dosage
/ Surgery
/ surgical procedures, operative
/ Uterine Cervical Neoplasms - drug therapy
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