Observational Prospective Cohort Study on Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Gastric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Peritoneal recurrence rate
研究概览
简要总结
The study investigates the outcomes of hyperthermic intraperitoneal chemoperfusion (HIPEC) in combination with curative-intent gastrectomy in resectable locally-advanced and limited-metastatic (low peritoneal cancer index) gastric cancer.
详细描述
Several recent studies showed that near-perfect curative-intent R0 surgical technique combined with systemic chemotherapy or even immunotherapy may not always be enough to eliminate microscopic deposits or eliminate peritoneal dissemination in locally advanced gastric cancer or low peritoneal cancer-index (PCI) tumors. The risk of peritoneal dissemination is especially high for T4 tumors, for those with cytologically positive peritoneal washings. Moreover, the risk of peritoneal relapse in low PCI tumors is remarkably high. Combination of surgery and intraperitoneal chemotherapy aims to minimise the risks of the aforementioned peritoneal progression. In the study investigators perform curative surgery followed by single dose of hyperthermic intraperitoneal chemotherapy (HIPEC).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hystologicaly proven gastric adenocarcinoma
- •ECOG status 0-1
- •Written consent to participate in the study
- •Medically and technically operable gastric tumor
- •Only T4a or T4b tumours with any peritoneal cytology status
- •Cytologically positive peritoneal washings (cyt+) with any T and N criteria
- •Adequate haemopoetic, renal and hepatic function (Hb > 120, PLT > 150*10^9/l, ALT < 60, AST <40, total bilirubin < 21 µmol/l, Creatinine clearance (male - 90-140, female - 80-130 ml/min)
排除标准
- •Pregnancy/breastfeeding
- •ECOG status 2-4
- •Concomitant malignancy
- •Mitomycin and/or Cisplatin hypersensitivity
- •Uncontrollable chronic diseases
- •Patients with coexisting malignancy other than basal cell carcinoma of the skin within the last five years.
- •Presence of metastases other than regional or peritoneal (such as liver, lungs, bone, brain, distant lymph nodes)
- •History of allergic reactions associated with cisplatin and Mitomycin C
- •Patients with psychiatric illness/social situations with impaired compliance
- •Refusal to participate
结局指标
主要结局
Peritoneal recurrence rate
时间窗: From enrolment up to 5 years of follow-up
Number of patients developed peritoneal recurence
次要结局
- Distant recurrence rate(Time from diagnosis up to 5 years of follow-up)
- Intraperitoneal chemotherapy complications rate(30 days after chemotherapy)
- 5-years relapse-free survival rate(Time from diagnosis up to 5 years of follow-up)
- Treatment-related quality of life assessed by Quality of Life Questionnaire-Stomach(6 months after treatment completion)
- Postoperative complications rate(30 days after surgery)
- 5-years overall survival(From the time of diagnosis up to 5 years of follow-up)
- Treatment-related quality of life assessed by Quality Of Life Questionnaire C30 version 3.0(6 months after treatment completion)
研究者
Oleksii Dobrzhanskiy
Physician
Ukrainian Society of Clinical Oncology