EUCTR2015-005695-15-NL
Active, not recruiting
Phase 1
Treatment of PERitoneal dissemination in Stomach Cancer patients with cytOreductive surgery and hyperthermic intraPEritoneal chemotherapy: the PERISCOPE II study - PERISCOPE II-study
KI-AV0 sites226 target enrollmentStarted: November 14, 2016Last updated:
ConditionsGastric 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)Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- KI-AV
- Enrollment
- 226
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •\- 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 42
Exclusion Criteria
- •\- 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
Investigators
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