2023-510159-53-01招募中2 期
Treatment of peritoneal dissemination in stomach cancer patients with cytoreductive surgery and hyperthermic intraperitoneal chemotherapy; PERISCOPE-2
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting18 个研究点 分布在 4 个国家目标入组 226 人开始时间: 2025年1月13日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 226
- 试验地点
- 18
- 主要终点
- Overall survival
研究概览
简要总结
The primary aim of this study is to compare the overall survival between gastric cancer patients with limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology treated with gastrectomy, cytoreductive surgery and HIPEC and those treated with the current standard treatment, i.e. systemic palliative chemotherapy.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Signed informed consent
- •Biopsy proven primary adenocarcinoma (or undifferentiated carcinoma) of the stomach. Including tumours at the oesophagogastric junction provided that the bulk of the tumour is located in the stomach, and, the intended surgical treatment is a gastric resection and not an oesophagectomy. A high intra-thoracic anastomosis is allowed, but not if a thoracotomy is necessary.
- •cT3-cT4 tumour (TNM classification, 7th edition(47)), considered to be resectable (including lymph nodes)
- •Limited peritoneal carcinomatosis (PCI <7) and/ or tumour positive peritoneal cytology confirmed by laparoscopy or laparotomy (paragraph 5.3.1 and 6.2) and proven by pathological examination
- •Treatment with systemic chemotherapy, with the latest course ending within 8 weeks prior to inclusion.
- •Absence of disease progression during systemic chemotherapy (prior to inclusion)
- •WHO performance status 0-2
- •Adequate bone marrow, hepatic and renal function. Minimally acceptable laboratory values at start of the study inclusion: o White blood cell count (WBC) >3.0*109/LPlatelet count ≥ 100 x 109 /L o Serum bilirubin ≤ 1.5 x ULN, and ALAT and ASAT ≤ 2.5 x ULN o Creatinine clearance ≥ 50 ml/min (measured or calculated by Cockcroft-Gault formula)
- •For female patients who are not sterilised or in menopause: o negative pregnancy test (urine/serum) o no breast feeding or active pregnancy ambition o reliable contraceptive methods
排除标准
- •Distant metastases (e.g., liver, lung, para-aortic lymph nodes; i.e., stations 14 and 16) or small bowel dissemination
- •Any medical condition not yet specified above that is considered to interfere with study procedures, including adequate follow-up and compliance and/or would jeopardise safe treatment
- •Uncontrolled diabetes mellitus
- •Pregnancy or breast feeding
- •Known hypersensitivity for any of the applied chemotherapeutic agents and/or their solvents
- •Recurrent gastric cancer
- •Prior resection of the primary gastric tumour
- •Non-synchronous peritoneal carcinomatosis
- •Current other malignancy (other than cervix carcinoma and basalioma)
- •Uncontrolled infectious disease or known infection with Human Immunodeficiency Virus type -1 or -2
- •A known history of hepatitis B or C with active viral replication
- •Recent myocardial infarction (< 6 months) or unstable angina
结局指标
主要结局
Overall survival
Overall survival
次要结局
- Progression free survival
- Treatment-related toxicity
- Costs and resource use
- Quality of life
- Genetic profiles related to tumour response (optional)
- pharmacokinetics and penetration depth of oxaliplatin and docetaxel (optional)
研究者
Judith Quik
Scientific
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
研究点 (18)
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