Surgery and abdominal chemotherapy for patient with peritoneal metastasized stomach cancer

Phase 1

• 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; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-002595-27-NL
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-23
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 20

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

- 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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified