Gastric Cancer Clinical Trial
Official title:
Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer
Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer
The gastric carcinoma is one of the four most common tumors occurring worldwide. The advanced
phase is characterized by metastasis and poses a very poor prognosis for survival. In 20%-30%
of gastric carcinomas the tumor spreads into the abdominal cavity, which leads to metastases
in the wall of the peritoneal cavity. This is known as peritoneal carcinomatosis and its
five-year survival rate is less than 2%. Even after R0 resection of a localized gastric
carcinoma the five-year survival rate is only 40%, not least of all because relapses in the
form of peritoneal metastases are a common occurrence.
Patients with gastric carcinoma and not yet diagnosed with metastases, but who show free
tumor cells in cytology in preoperative laparoscopy before neoadjuvant chemotherapy and
gastrectomy, have an 80% risk of developing peritoneal carcinomatosis within one year, which
stands in strong contrast to the 40% risk for patients with negative cytology.
In the study presented here (group A) therapeutic hyperthermic intraperitoneal chemoperfusion
(HIPEC, in the literature also known as HIIC (heated intraoperative intraperitoneal
chemotherapy) or IPHC (intraperitoneal chemohyperthermia)) with mitomycin c and cisplatin
will be administered following gastrectomy in patients with a gastric carcinoma with free
tumor cells in cytology diagnosed in the preoperative laparoscopy in comparison to (group B)
solely gastrectomy in patients with a gastric carcinoma and also with free tumor cells
diagnosed in cytology in the preoperative laparoscopy.
A randomization will be performed between group A and B. Patients with gastric carcinoma (TNM
Stage ≥ T2<T4) without proven metastases (TNM stage M0), with and without involved regional
lymph nodes (TNM stage +N/-N) and positive cytology in preoperative abdominal lavage will be
included. Exclusion criteria are extended disease or inoperable tumor.
This study is already permitted by the local ethic commission and the German Federal
Institute for Drugs and Medical Devices (BfArM) (EudraCT-Nr.: 2011-004405-25 / Study code:
HIPEC_Stomach) and was initiated in August 2012.
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