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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45753

Enrollment

Registered

2017-03-15

Start date

2017-08-28

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Gastric peritoneal carcinomatosis Metastasized Stomach Cancer

Interventions

Hyperthermic Intraperitoneal Chemotherapy and Cytoreductive Surgery.

Gastric Cancer

HIPEC

Peritoneal carcinomatosis

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Histologically proven adenocarcinoma of the stomach. - Surgical resectable carcinoma (T1-4b, N1-3) (table 1) - 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

Exclusion criteria

Exclusion criteria: - Distant metastases other than peritoneal metastases - Siewert type I/II 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
Primary outcome is the safety and feasibility of the intervention, measured by the percentage of overall surgical complications	—

Secondary

Measure	Time frame
Secondary outcomes are mortality, postoperative recovery, quality of life, disease free and overall survival	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)