Phase II Trial of Surgical Resection and Heated Intraperitoneal Peritoneal Chemotherapy (HIPEC) for Adrenocortical Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Progression Free Survival
研究概览
简要总结
Objectives:
- To determine intraperitoneal (IP) progression free survival after optimal debulking and heated intraperitoneal chemotherapy (HIPEC) with cisplatin in patients with IP spread of adrenocortical cancer.
- Determine morbidity of this procedure in this patient population.
- Determine the impact of surgery and HIPEC on quality of life (QOL) and hormone excess.
- Examine patterns of recurrence (local versus systemic).
- Determine overall survival after optimal debulking and HIPEC in patients with IP spread of adrenocortical cancer.
详细描述
Adrenocortical carcinoma (ACC) is a rare tumor with an overall 5-year mortality rate of 75 - 90% and an average survival from the time of diagnosis of 14.5 months. The treatment of choice for a localized primary or recurrent tumor is surgical resection of all visible tumor and involved organs. For unresectable metastatic or recurrent disease, mitotane, aminoglutethimide, metapyrone, and ketoconazole are used. This would be the standard of care alternative treatment.
Cisplatin is one of the most effective chemotherapeutic agents for ACC. Phase I and II trials using heated intraperitoneal (IP) chemotherapy with cisplatin have been conducted in other tumors that spread primarily to the peritoneal lining of the abdomen. Synergy has been demonstrated for cisplatin and hyperthermia. The purpose of this trial is to determine if an surgical approach with intraperitoneal administration of heated cisplatin when tumor volume is minimal, can impact and improve on progression free survival.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Surgery with HIPEC
Cytoreductive surgery followed by HIPEC with cisplatin and sodium thiosulfate
干预措施: Cisplatin (Drug)
Surgery with HIPEC
Cytoreductive surgery followed by HIPEC with cisplatin and sodium thiosulfate
干预措施: Sodium thiosulfate (Drug)
Surgery with HIPEC
Cytoreductive surgery followed by HIPEC with cisplatin and sodium thiosulfate
干预措施: Cytoreductive surgery (Procedure)
结局指标
主要结局
Progression Free Survival
时间窗: Up to 5 years
The length of time after optimal debulking and heated intraperitoneal chemotherapy that a patient lives before there is clinical evidence of recurrent adrenocortical cancer.
次要结局
- Morbidity Rate(Up to 5 years)
- Quality of Life (QOL) Score(Up to 5 years)
- Overall Survival(Up to 5 years)
研究者
Kazuki Sugahara
Assistant Professor of Surgery
Columbia University