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.

Treatment of PERitoneal dissemination in Stomach Cancer patients with cytOreductive surgery and hyperthermic intraPEritoneal chemotherapy: the PERISCOPE II study - PERISCOPE II-study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005695-15-NL

Enrollment

226

Registered

2016-11-14

Start date

2017-07-14

Completion date

Unknown

Last updated

2025-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric cancer with peritoneal carcinomatosis or tumour positive cytology MedDRA version: 20.0 Level: HLT Classification code 10017812 Term: Gastric neoplasms malignant System Organ Class: 100000004856 MedDRA version: 21.0 Level: PT Classification code 10061269 Term: Malignant peritoneal neoplasm System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 10057647 Term: Cytoreductive surgery System Organ

Interventions

Trade Name: Eloxatin Pharmaceutical Form: Concentrate for solution for infusion Trade Name: Docetaxel Sandoz Pharmaceutical Form: Concentrate and solvent for solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age = 18 years - cT3-cT4 adenocarcinoma (or undifferentiated carcinoma) of the stomach, considered to be resectable - Limited peritoneal carcinomatosis (PCI =65 years) yes F.1.3.1 Number of subjects for this age range 64

Exclusion criteria

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 - Known hypersensitivity for any of the applied chemotherapeutic agents and/or their solvents

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: - To compare the progression free 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. palliative systemic chemotherapy. - To study treatment-related toxicity in gastric cancer patients with limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology treated with gastrectomy, cytoreductive surgery and HIPEC. - To compare the costs and health benefits of a gastrectomy in combination with cytoreductive surgery and HIPEC, to the costs and health benefits of standard palliative systemic chemotherapy in patients with limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology. - To identify genetic profiles related to tumour response in gastric cancer patients with limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology. (Optional);Primary end point(s): Overall survival;Timepoint(s) of evaluation of this end point: Overall survival will be calculated when 80 deaths are observed.	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: - To compare the progression free 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. palliative systemic chemotherapy. - To study treatment-related toxicity in gastric cancer patients with limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology treated with gastrectomy, cytoreductive surgery and HIPEC. - To compare the costs and health benefits of a gastrectomy in combination with cytoreductive surgery and HIPEC, to the costs and health benefits of standard palliative systemic chemotherapy in patients with limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology. - To identify genetic profiles related to tumour response in gastric cancer patients with limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology. (Optional);Primary end point(s): Overall survival;Timepoint(s) of evaluation of this end point: Overall survival will be calculated when 80 deaths are observed.

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Secondary

Measure	Time frame
Secondary end point(s): - Progression free survival - Treatment-related toxicity - Costs and resource use - Quality of life, utilities - Genetic profiles related to tumour response (optional);Timepoint(s) of evaluation of this end point: 4 years	—

Countries

Denmark, Finland, Netherlands

Contacts

Public ContactJohanna van Sandick

NKI-AVL

j.v.sandick@nki.nl00310205121111

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026