NCT00454519Unknown2 期
Cytoreductive Surgery Plus Intraoperative Peritoneal Hyperthermic Chemotherapy for the Treatment of Peritoneal Carcinomatosis From Gastrointestinal Cancer: an Open Label, Randomized, Prospective, Phase 2 Clinical Trial
Wuhan University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2007年3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
- 60
- 试验地点
- 1
- 主要终点
- overall survival time
研究概览
简要总结
OBJECTIVES:
- Determine response and survival of patients with peritoneal carcinomatosis treated with cytoreductive surgery plus intraoperative peritoneal hyperthermic chemotherapy with cisplatin and mitomycin
- Assess the quality of life of patients treated with this regimen.
OUTLINE: Patients are randomized into IPHC group and control group. In the former group, the patients undergo cytoreductive surgery plus intraoperative hyperthermic peritoneal perfusion with cisplatin and mitomycin over 60 minutes. Patients in the control group just underwent routine cytoreductive surgery.
All patients in both groups receive the standard conventional chemotherapy after surgery.
Quality of life is assessed at study initiation, at 1, 3, 6 months. Patients are followed at 4 weeks, every 3 months for 1 year, and then every 6 months for up to 3 years.
详细描述
DISEASE CHARACTERISTICS:
- Histologically confirmed peritoneal carcinomatosis with the following histologies:
- Primary peritoneal mesothelioma
- Adenocarcinoma of gastrointestinal tract origin
- Confined to peritoneal cavity
- Tumor mass could be debulked to less than 2.5 cm in diameter per tumor deposit
- Must not have failed prior intraperitoneal platinum therapy
- Treatment failure is defined as radiographic evidence of disease progression on 2 consecutive CT scans within 3 months after therapy
PATIENT CHARACTERISTICS:
Age:
- 20 to 70 years old
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gastric cancer or colorectal cancer with peritoneal carcinomatosis
- •Gastric cancer or colorectal cancer with malignant ascites
- •Karnofsky Performance Scale(KPS)>50
排除标准
- •Age less than 20 years old, or beyond 70 years old
- •Any lung metastasis, liver metastasis, or prominent retroperitoneal lymph node metastasis
- •Bilirubin greater than 3 times upper limit of normal (ULN)
- •AST and ALT greater than 5 times ULN
- •Liver enzymes greater than 3 times ULN
结局指标
主要结局
overall survival time
时间窗: from operation to death due to cancer recurrence
次要结局
- perioperative morbidity and mortality(Within 30 days postoperation)
研究者
研究点 (1)
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