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Hyperthermia

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Gastrointestinal Neoplasms

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Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Doxorubicin

Liposomal doxorubicin

Cisplatin

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.

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

intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC)

Alfred Königsrainer, MD

Can Yurttas, MD

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

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.

Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Gastric Cancer

Phase II Pilot Study to Reduce the Incidence of Peritoneal Carcinoma After Curative Gastrectomy of Gastric Carcinoma or Adenocarcinoma of Gastroesophageal Transition by Hyperthermic Intraperitoneal Chemoperfusion

The primary objective of the study is to estimate the effect of a combined therapy with gastrectomy and HIPEC in localized advanced gastric cancer. The primary target is the incidence of peritoneal metastases in CT and the proportion of patients who after one year are free from peritoneal metastasis. The study is intended to provide planning data for a subsequent Phase III study in the form of an RCT.

Progression-free survival (PFS) based on imaging (CT).

Expected adverse events (AEs) of particular interest must be recorded from grade ≥ III according to CTCAE v5.0 or postoperative complications according to Clavien-Dindo classification from grade ≥ 3b by AE/ADR reporting.

Unexpected and expected AEs must be documented and reported as SAE from grade IV according to CTCAE v5.0 or from grade 4-5 according to Clavien-Dindo classification.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Gastric Cancer	NCT04180761	Gastric Neoplas...	intraoperative ...	18 Years -	University Hospital Tuebingen
Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Gastric Cancer	NCT04180761	Gastric Neoplas...	intraoperative ...	18 Years -	University Hospital Tuebingen

Spots Global Cancer Trial Database for intraoperative hyperthermic intraperitoneal chemotherapy (hipec)