Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Gastric Cancer

NCT ID: NCT04180761

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-30
• Study Completion Date: 2022-09-30

Brief Summary

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

Detailed 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.

Conditions

Gastric Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HIPEC-Treatment

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.

Group Type: EXPERIMENTAL

intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC)

Intervention Type: DRUG

single dose application of hyperthermic intraperitoneal chemotherapy (HIPEC) at 42.5°C for 60 minutes after the gastrectomy

Interventions

intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC)

single dose application of hyperthermic intraperitoneal chemotherapy (HIPEC) at 42.5°C for 60 minutes after the gastrectomy

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Tuebingen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Department of General, Visceral and Transplant Surgery

Tübingen, Baden-Wurttemberg, Germany

Countries

Germany

Other Identifiers

ProPeC

Identifier Type: -

Identifier Source: org_study_id