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临床试验/NCT03792867
NCT03792867进行中(未招募)不适用

Radical Resection and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of High Risk Recurrent Retroperitoneal Sarcoma

National Cancer Centre, Singapore1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2018年7月23日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
5
试验地点
1
主要终点
Incidence of treatment-related adverse events

研究概览

简要总结

Retroperitoneal sarcoma is a rare cancer that accounts for 15% of soft tissue sarcomas and affects many young people. In approximately 50% of patients, the tumour will reappear in the same area regardless of therapy. Current treatment involves radical resection; however, it does not significantly reduce recurrence rates or improve overall survival. Recurrent retroperitoneal sarcoma does not respond well to chemotherapy and prognosis is often guarded. One of the main challenges in the surgical treatment of this disease is the ability to accurately identify the local extension of the disease and to prevent local recurrence.

At present, there are no options to prevent recurrence after surgery. In recent years, there has been increased interest in the use of combined radical surgery with heated intraperitoneal chemotherapy (HIPEC). Radical resection is defined as en-bloc resection of the tumour including but not limited to surrounding organ resection and normal fat. This is in combination with the use of HIPEC. HIPEC is the use of chemotherapy in the intraperitoneal cavity that is heated to 40 to 42 degree Celsius.

Surgery coupled with HIPEC has shown to reduce recurrence in colorectal cancer, appendiceal cancer and mesothelioma. We hypothesize that HIPEC when coupled with radical surgery will improve the overall outcomes of patients with retroperitoneal sarcomatosis. We hope to learn if this treatment approach will increase locoregional control to reduce recurrence rates and improve 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
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Disease Characteristics
  • Histologically proven soft tissue sarcoma of one of following high-risk groups:
  • Tumours with grade 2 or 3 histology
  • Size more than or equal to 5cm
  • Extracompartmental and deep extension
  • Local recurrence of primary tumour
  • Inadequate surgical excision of previously operated on tumour
  • Proven diagnosis of recurrent retroperitoneal sarcoma confirmed by imaging modality and/ or intraoperative biopsy
  • Patient Characteristics
  • Age: ≥21 years old
  • Performance status: ECOG 0-1
  • Normal haematological, hepatic, coagulation, renal and electrolyte profiles
  • Normal left ventricular ejection fraction
  • Not pregnant or nursing

排除标准

  • Patient is medically unfit for surgery due to concurrent medical comorbidities.
  • Any medical or psychiatric condition(s) which would preclude informed consent.
  • Patient is pregnant or nursing.

研究组 & 干预措施

Radical Resection and HIPEC

Experimental

干预措施: Doxorubicin (Drug)

结局指标

主要结局

Incidence of treatment-related adverse events

时间窗: From time of resection to one year post-surgery

To evaluate chemotherapy toxicity and unforeseen acute and late complications associated with the treatment

次要结局

  • Local recurrence-free survival(From time of resection until first occurrence of disease recurrence, up to 3 years)
  • Overall survival(From time of resection to death from any cause, up to 3 years)

研究者

发起方
National Cancer Centre, Singapore
申办方类型
Other
责任方
Sponsor

研究点 (1)

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