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

Phase 2

Completed

• Conditions: Gastric peritoneal carcinomatosis; Metastasized Stomach Cancer; 10017990; 10027476; 10017998

• Registration Number: NL-OMON45753
• Lead Sponsor: Heelkunde, chirurgie

Brief Summary

Trial ended prematurely

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-04-23
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 3

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

- 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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome is the safety and feasibility of the intervention, measured by<br /><br>the percentage of overall surgical complications</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are mortality, postoperative recovery, quality of life,<br /><br>disease free and overall survival</p><br>