Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Gastric Cancer (ProPeC)

University Hospital Tuebingen

Status and phase: Withdrawn; Phase 2

Conditions: Gastric Neoplasms

Treatments: Drug: intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC)

Study type: Interventional

Funder types: Other

Identifiers

NCT04180761

ProPeC

Details and patient eligibility

About

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

Full description

An operation and the constant further development of the surgical techniques can not always prevent the recurrence of a tumor of the stomach or the transition from the esophagus to the stomach. As reason for this recurrence, the investigators assume that the tumor was already present at the time of the surgery and has crossed the boundaries of the stomach or free tumor cells are located in the peritoneal cavity, even if they can't be found with the bare eye or imaging methods. Such free tumor cells have the possibility of developing metastases within the abdominal cavity.

An innovative local treatment method is being tested in Tübingen and applied to remove any remaining free tumor cells or very small and invisible residual tumors. These free tumor cells can be determined prior to the start of treatment by peritoneal endoscopy (diagnostic laparoscopy). If these can be identified by lavage of the abdominal cavity there is an increased risk for the development of peritoneal metastases. Therefore, in patients with detected free tumor cells in the lavage water of the abdominal cavity, after the removal of the stomach, should be used once a chemotherapy in the abdominal cavity, which is warmer than the body (intraoperative hyperthermic chemotherapy, HIPEC). In this study the investigators want to demonstrate, that the single administration of intraoperative HIPEC with cisplatin and doxorubicin in addition to routine surgery delays the onset of peritoneal metastases and the additional therapy with its low risks is reasonable.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

HIPEC-Treatment

Experimental group

Description:

Doxorubicin (15 mg/m²/body surface) Cisplatin (75 mg/m²/body surface) applied as hyperthermic intraperitoneal chemotherapy (HIPEC) at 42.5°C for 60 minutes after the gastrectomy. All drugs used are approved.

Treatment:

Drug: intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC)