Surgery and abdominal chemotherapy for patient with peritoneal metastasized stomach cancer

Cytoreductive surgery and Intraperitoneal chemotherapy and for Stomach CAncer: a feasibility study - CISCA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002595-27-NL

Enrollment

Registered

2017-03-23

Start date

2017-05-30

Completion date

Unknown

Last updated

2019-02-28

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

Conditions

Peritoneal carcinomatosis of gastric origin MedDRA version: 20.0 Level: LLT Classification code 10017767 Term: Gastric cancer stage IV with metastases System Organ Class: 100000004864

Interventions

Trade Name: Cisplatin Accord Pharmaceutical Form: Concentrate for solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Histologically proven adenocarcinoma of the stomach. - Surgical resectable carcinoma (T1-4a, N1-3) (table 1) - Clinical or pathological proven peritoneal metastases - Peritoneal Cancer Index (PCI) =12 - European Clinical Oncology Group (ECOG) performance status 0,1 or 2 - Age = 18 - Written informed consent 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: - Distant metastases other than peritoneal metastases - Siewert type I gastro-esophageal junction tumor. - Peritoneal carcinomatosis as a presentation of recurrent disease - Pregnancy - Contraindication to cisplatin (e.g. hypersensitivity, HIV infection and inadequate bone marrow, hepatic or renal function)

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the safety and feasibility of HIPEC and CS in Western patients with peritoneal metastases of gastric cancer, in terms of morbidity and mortality. ;Secondary Objective: Secondary objective is to determine the effect on survival and recurrence. ;Primary end point(s): Primary outcome is the percentage of overall surgical complications grade 3 and higher as stated by the Common Terminology Criteria for Adverse Events. ;Timepoint(s) of evaluation of this end point: After discharge of last patient	—

Measure

Time frame

Main Objective: To assess the safety and feasibility of HIPEC and CS in Western patients with peritoneal metastases of gastric cancer, in terms of morbidity and mortality. ;Secondary Objective: Secondary objective is to determine the effect on survival and recurrence. ;Primary end point(s): Primary outcome is the percentage of overall surgical complications grade 3 and higher as stated by the Common Terminology Criteria for Adverse Events. ;Timepoint(s) of evaluation of this end point: After discharge of last patient

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary outcomes are mortality, events related to HIPEC, operation related events and postoperative recovery, including quality of life, disease free and overall survival.;Timepoint(s) of evaluation of this end point: 5 years after surgery of the last patient	—

Countries

Netherlands

Contacts

Public ContactStudy Coordinator

UMC Utrecht

shorst2@umcutrecht.nl310887573479

Outcome results

None listed

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