EUCTR2015-005695-15-DK招募中1 期
Treatment of PERitoneal dissemination in Stomach Cancer patients with cytOreductive surgery and hyperthermic intraPEritoneal chemotherapy: the PERISCOPE II study - PERISCOPE II-study
KI-AV0 个研究点目标入组 10 人开始时间: 2022年9月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •- Age = 18 years
- •- cT3-cT4 adenocarcinoma (or undifferentiated carcinoma) of the stomach, considered to be resectable
- •- Limited peritoneal carcinomatosis (PCI <7) and/ or tumour positive peritoneal cytology (proven by laparoscopy or laparotomy)
- •- Absence of disease progression during prior systemic chemotherapy
- •- WHO performance status 0-2
- •- Adequate bone marrow, hepatic and renal function
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •- Distant metastases or small bowel dissemination
- •- Recurrent gastric cancer
- •- Prior resection of the primary gastric tumour
- •- Non-synchronous peritoneal carcinomatosis
- •- Current other malignancy (other than cervix carcinoma and basalioma)
- •- Hepatitis B or C, known HIV infection or an uncontrolled infectious disease
- •- Recent myocardial infarction (< 6 months) or unstable angina
- •- Uncontrolled diabetes mellitus
- •- Pregnancy or breast feeding
- •- Any medical condition that is considered to interfere with study procedures and/or would jeopardize safe treatment
- •- Known hypersensitivity for any of the applied chemotherapeutic agents and/or their solvents
研究者
相似试验
招募中
3 期
Treatment of PERitoneal dissemination in Stomach Cancer patients with cytOreductive surgery and hyperthermic intraPEritoneal chemotherapy: the PERISCOPE II studyAdenocarcinoma of the stomach100179901001799110017998gastric cancerNL-OMON53132Antoni van Leeuwenhoek Ziekenhuis226
进行中（未招募）
1 期
A study designed to compare the effect of two treatment types in gastric cancer patients with peritoneal metastasis, standard systemic chemotherapy vs surgery combined with hyperthermic chemotherapy in the abdominal cavity.Gastric cancer with peritoneal carcinomatosis or tumour positive cytologyMedDRA version: 20.0Level: HLTClassification code 10017812Term: Gastric neoplasms malignantSystem Organ Class: 100000004856MedDRA version: 21.0Level: PTClassification code 10061269Term: Malignant peritoneal neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10057647Term: Cytoreductive surgerySystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 21.1Level: LLTClassification code 10067093Term: Intraperitoneal hyperthermic chemotherapySystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0Level: PTClassification code 10061965Term: GastrectomySystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0Level: LLTClassification code 10052171Term: Peritoneal carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2015-005695-15-NLKI-AV226
进行中（未招募）
不适用
Treatment of PERItoneal dissemination in Stomach Cancer patients with cytOreductive surgery and hyperthermic intraPEritoneal chemotherapyGastric cancer with peritoneal carcinomatosis or positive peritoneal cytology.MedDRA version: 16.0Level: HLTClassification code 10017812Term: Gastric neoplasms malignantSystem Organ Class: 100000004856MedDRA version: 16.0Level: PTClassification code 10067093Term: Intraperitoneal hyperthermic chemotherapySystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2013-000138-37-NLKI-Av
招募中
不适用
Treatment of PERItoneal dissemination in Stomach Cancer patients with cytOreductive surgery and hyperthermic intraPEritoneal chemotherapyadenocarcinoma of the stomach100179901001799110017998gastric cancerNL-OMON41435Antoni van Leeuwenhoek Ziekenhuis30
尚未招募
不适用
Treatment of peritoneal metastases in stomach cancer patients with extensive surgery and heated intraperitoneal chemotherapyNL-OMON21196The Netherlands Cancer Institute – Antoni van Leeuwenhoek Hospital, Amsterdam, The NetherlandsSt. Antonius Hospital, Nieuwegein, The Netherlands30