Primary chemoradiation versus neoadjuvant chemotherapy followed by surgery as treatment strategy for locally advanced vulvar carcinoma (VULCANize2)

Stichting Het Nederlands Kanker Instituut-Antoni Van Leeuwenhoek Ziekenhuis0 个研究点目标入组 98 人开始时间: 2023年5月10日最近更新: 2024年7月22日

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阶段: 1 期
状态: 招募中
发起方: Stichting Het Nederlands Kanker Instituut-Antoni Van Leeuwenhoek Ziekenhuis
入组人数: 98

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•Woman = 18 years, Beta HCG level of 14 mIU/mL or below for women of childbearing potential, Highly effective contraception for patients if the risk of conception exists, Highly effective contraception for patients if the risk of conception exists, Signed and written informed consent, Histologically-confirmed primary or recurrent squamous cell carcinoma vulvar cancer FIGO stage Ib – IVa, T1b or higher, any N, M0, Local tumour through which the size or localization implies requirement of treatment through primary chemoradiation or surgery consisting of extensive surgery (meaning surgery damaging pelvic organs or exenterative surgery). This can imply: T1b or larger tumour with (irresectable) groin metastases. Or this can imply: T1b or larger tumour with a close relationship to and/or involvement of the urethra or anal sphincter, World Health Organization performance status of 0-2, Adequate haematological function defined by platelet count >100x10E9/L, absolute neutrophil count >1.5x10E9/L, and hemoglobin >6.0 mmol/L, Adequate hepatic function defined by a total bilirubin level =1.5x the upper limit of normal range and ASAT and ALAT levels =2.5x ULN for all subjects, Adequate renal function defined by an estimated creatinine clearance =50mL/min according to the Cockroft-Gault formula (or local institutional standard method)

•Patients with highly suspicious or positive metastases to the pelvic lymph nodes, Any psychiatric condition that would prohibit the understanding or rendering of informed consent, Prior radiotherapy to the pelvis or groin area limiting full dose chemoradiation according to protocol, Existing neuropathy which will hinder the intake of chemotherapy, Patients eligible for radical local excision without involvement of other organs

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