Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Gastric Cancer

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study investigates the effect of a combined therapy with gastrectomy and HIPEC in localized advanced gastric cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Tuebingen

Criteria

Inclusion Criteria:

• Written informed consent of the patient

• Positive lavage cytology in staging laparoscopy

• Intraoperative R0- or R1-gastrectomy (Re-evaluation intraoperative)

• Histologically confirmed locally advanced, resectable Adenocarcinomas of the stomach (incl. AEG II-III): >cT3 and/or cN+ and cM0 (none existing solid Peritoneal metastases, Re-evaluation intraoperative)

• Neoadjuvant chemotherapy ≥ 2 cycles

Exclusion Criteria:

• < 18 years

• Existence of contraindications or contraindications against the study medication

• Uncompensated Heart Failure (NYHA III and IV)

• Severe CHD, medically insufficient treatable cardiac arrhythmias, uncontrolled arterial hypertension

• Serum creatinine ≥ 1.5 x the standard value or a Creatinine clearance < 60 ml/min/1.73 m2

• Severe pulmonary dysfunction (COPD, PAH), Pulmonary function test confirmed (IVC < 55 %, DLCO < 40%)

• malignant secondary tumor disease that persists for < 5 years (Exception: in situ carcinoma of the cervix, adequately treated basal cell carcinoma of the skin)

• Participation in other interventional studies that at the time of the ProPeC study inclusion, still are not finished

• pregnancy or lactation