Gastric Neoplasms Clinical Trial
Official title:
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
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.
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