跳至主要内容
临床试验/EUCTR2019-000851-15-NL
EUCTR2019-000851-15-NL进行中(未招募)1 期

Treatment of metastatic vulvar carcinoma in a neoadjuvant setting with Carboplatin and Paclitaxel chemotherapy - CRAVAT

KI-AV0 个研究点目标入组 12 人开始时间: 2019年11月27日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
12

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Female

入选标准

  • Woman = 18 years
  • Signed and written informed consent.
  • Histologically confirmed squamous cell vulvar carcinoma
  • World Health Organization performance status of 0-2
  • Adequate hematological function
  • Adequate hepatic function
  • Adequate renal function
  • Negative pregnancy test for woman of childbearing potential
  • Histologically or CT scan confirmed metastatic squamous cell vulvar carcinoma
  • Measurable disease
  • Lesion previously not irradiated
  • TNM stage any T any N M1
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 2
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 10

排除标准

  • Vulvar cancer other than squamous cell carcinoma at biopsy
  • Previous radiotherapy of the vulva, groins or pelvis
  • Patients with metastasis limited to the pelvic lymph nodes, who can be primarily operated with curative intent
  • Other diagnosis of malignancy or evidence of other malignancy for 5 years before screening for this study

研究者

发起方
KI-AV

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