Cytoreductive Surgery (CRS) With/Without HIPEC in Gastric Cancer With Peritoneal Carcinomatosis
Condition: Malignant Neoplasm of Stomach; Secondary Malignant Neoplasm of Peritoneum; Secondary Malignant Neoplasm of Other and Unspecified Sites
MeSH terms: Neoplasms; Stomach Neoplasms; Neoplasm Metastasis; Carcinoma; Peritoneal Neoplasms; Neoplasms, Second Primary
Study type: Interventional
Phase: Phase 3

Summary: 
      Patients with histological proven gastric cancer (including cancer of the esophagogastric
      junction (AEG)) and synchronous peritoneal carcinomatosis, who fulfill the inclusion and
      exclusion criteria, can be recruited in this study. There are two treatment groups (A and B).
      The chemotherapy applied intravenously is the same in both groups and is approved for the
      treatment of gastric cancer. Patients with negative or unknown HER-2 status will be
      administered Epirubicin, Oxaliplatin and Capecitabine (EOX). Patients with positive HER-2
      status will be treated with Cisplatin, Capecitabine and Trastuzumab (CCT).

      The chemotherapy is followed by surgical cytoreduction in both groups. Patients randomized
      into group B will be treated with an intraperitoneal (in the abdominal cavity) chemoperfusion
      with Mitomycin C and Cisplatin .

      Patients in both groups receive 3 cycles of postoperative chemotherapy within 4-12 weeks
      after the surgical procedure and are followed up for 30 months.

      If progress of the tumor is detected the patient will no longer be treated according to the
      study therapy. Patients of group B may get a HIPEC intervention without surgical
      cytoreduction if contraindication to the drugs applied can be excluded.
    

Detailed description: 
      The objective of the trial is to compare the treatment of patients with peritoneal
      metastasized gastric cancer including carcinoma of the AEG (Adenocarcinoma of the
      oesophago-gastric-junction) without evidence of other distant metastases treated with
      neoadjuvant chemotherapy followed by cytoreduction with intraperitoneal chemoperfusion
      (HIPEC) and postoperative chemotherapy (Group B) and patients treated with cytoreduction
      alone after neoadjuvant chemotherapy and postoperative chemotherapy (Group A).

      Hypothesis of the trial is that surgical cytoreduction with intraperitoneal chemoperfusion
      (Group B) is superior to cytoreduction alone (Group A) in terms of overall survival.

      The trial is designed as a prospective, randomized, open, multicenter and parallel group
      study.
    

Intervention name(s): HIPEC
Intervention type(s): Procedure
Intervention description(s): HIPEC:
Mitomycin C: 15 mg/m2 (max. 30 mg/ m2, max. 5 L Perfusion). Cisplatin: 75 mg/m2/L (max. 150 mg/m2, max. 5 L Perfusion). 4-12 weeks after cytoreductive surgery 3 cycles postoperative chemotherapy will be applied.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: intraperitoneal (in the abdominal cavity) chemoperfusion with Mitomycin C and Cisplatin
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastric cancer; cancer of the esophagogastric junction; peritoneal carcinomatosis; hyperthermic intraperitoneal chemotherapy; HIPEC