EUCTR2016-002595-27-NL
Active, not recruiting
Phase 1
Cytoreductive surgery and Intraperitoneal chemotherapy and for Stomach CAncer: a feasibility study - CISCA
ConditionsPeritoneal carcinomatosis of gastric originMedDRA version: 20.0 Level: LLT Classification code 10017767 Term: Gastric cancer stage IV with metastases System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
DrugsCisplatin Accord
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Peritoneal carcinomatosis of gastric origin
- Sponsor
- niversity Medical Center Utrecht
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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)
Outcomes
Primary Outcomes
Not specified
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