Treatment of Metastatic Vulvar Carcinoma With Carboplatin and Paclitaxel Chemotherapy (CRAVAT)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- tumour size reduction by neo adjuvant chemotherapy
研究概览
简要总结
Vulvar cancer is a rare malignancy. Surgery is the treatment of choice, but frequently causes invalidating and chronic postoperative morbidity, especially in patients with high stage disease. Theoretically, downstaging with neo adjuvant chemotherapy could shrink the tumour, making surgical treatment less extensive thereby diminishing the chance for morbidity.
详细描述
Vulvar cancer is a rare malignancy. Surgery is the treatment of choice, but frequently causes invalidating and chronic postoperative morbidity, especially in patients with high stage disease. Theoretically, downstaging with neo adjuvant chemotherapy could shrink the tumour, making surgical treatment less extensive thereby diminishing the chance for morbidity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
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
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
研究组 & 干预措施
neo adjuvant Paclitaxel and Carboplatin
6 courses of Paclitaxel 175 mg/m2 and Carboplatin AUC 5 in a 3 weekly schedule
干预措施: Paclitaxel and Carboplatin (Drug)
结局指标
主要结局
tumour size reduction by neo adjuvant chemotherapy
时间窗: 18 weeks
tumour size reduction measured by RECIST 1.1
次要结局
- overall survival(5 years after treatment)
- chemotherapy related morbidity(21 weeks)