NCT02595021Unknown2 期
A Phase II Study of Total or Subtotal Colectomy in Stage IIIC and Stage IV Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer (EOC, FTC, PPC)
Shanghai Gynecologic Oncology Group1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2015年7月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Postoperative complications
研究概览
简要总结
The purpose of this study is to evaluate the safety and one year disease-free survival of total or subtotal colectomy and proctocolectomy in stage IIIc and stage IV epithelial ovarian, fallopian tube, and primary peritoneal cancer (EOC, FTC, PPC).
详细描述
This trial is to assess the perioperative complications, hospitalization expenses and days, and one year disease-free survival of patients who underwent total or subtotal colectomy as part of the surgical procedures for ovarian cancer, versus partial intestinal resection in the therapy for ovarian cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years and ≤ 75 years.
- •Epithelial ovarian cancer, fallopian tube cancer, primary peritoneal carcinoma with pathology confirmed International Federation of Gynecology and Obstetrics (FIGO) stage IIIc or IV
- •Extensive colonic metastasis, tumor involving the major part of bowel surface and/or mesentery
- •Optimal cytoreductive surgery, including hysterectomy, bilateral salpinges-oophorectomy, omentectomy, and resection of all metastatic lesions, with a residual disease no more than 0.5cm
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •American Society of Anesthesiologists (ASA) performance 1-
- •Follow-up available.
- •Written informed consent.
排除标准
- •Low-malignant potential ovarian tumor.
- •Patient who underwent enterostomy in the surgery procedure.
- •Tumor involving small intestine alone.
- •More than 2 anastomoses.
- •Other condition that could interfere with provision of informed consent, compliance to study procedures, or follow-up.
- •Prior invasive malignancies within the last 5 years showing activity of disease.
结局指标
主要结局
Postoperative complications
时间窗: up to 30 days after surgery
Assessed by Common Terminology Criteria for Adverse Events version 4.0 up to 30 days after surgery
次要结局
- The rate of 12- month- disease non-progression(up to 12 months)
- Initiation of the first cycle chemotherapy(up to 12 weeks)
- Hospitalization expenses(up to 12 weeks)
- Hospitalization days(up to 12 weeks)
研究者
研究点 (1)
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