Neoplasms

All Conditions

Digestive System Diseases

Symptoms and General Pathology

Wounds and Injuries

Rare Diseases

Adenocarcinoma

Stomach Neoplasms

Neoplasm Metastasis

Hyperthermia

Fever

Peritoneal Neoplasms

Carcinoma

Neoplasms, Second Primary

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Neoplastic Processes

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Abdominal Neoplasms

Peritoneal Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Trastuzumab

Oxaliplatin

Capecitabine

Cisplatin

Epirubicin

Mitomycins

Mitomycin

Preoperative chemotherapy 3 cycles, each cycle 21 days. Patients with negative or unknown HER-2 status receive Epirubicin 50 mg/m² infusion (maximum 100mg/d). Oxaliplatin 130 mg/m² infusion (maximum 260 mg/d) and capecitabine oral 625 mg/m² two times a day (maximum 2500 mg/d).

Patients with positive HER-2 status receive:

Cisplatin : 80 mg/m² infusion (maximum of 160 mg/d). Capecitabine: oral 1000 mg/m2 (two times a day maximum of 4000 mg/d), on day 1-14.

Trastuzumab: 8 mg/kg infusion (on cycle 1 and 6 mg/kg on cycle 2 and 3). CRS is performed and 4-12 weeks after CRS 3 cycles of postoperative chemotherapy have to be applied. In case of therapy failure patients will be continued to be treated by the responsible investigator according to his medical status.

Patients will be treated with a preoperative chemotherapy as described for the control group. EOX or CCT depending on the HER-2 status.

CRS will be performed 2 to 3 weeks after end of last chemotherapy cycle. HIPEC with mitomycin C and cisplatin either at the time of CRS or a delayed HIPEC within 5-7 days.

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.

Patients may get a HIPEC intervention without surgical cytoreduction if contraindication to the drugs can be excluded.

In case of therapy failure patients will be continued to be treated by the responsible investigator according to his medical status.

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.

HIPEC

Beate Rau, Prof.

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.

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.

intraperitoneal (in the abdominal cavity) chemoperfusion with Mitomycin C and Cisplatin

Cytoreductive Surgery (CRS) With/Without HIPEC in Gastric Cancer With Peritoneal Carcinomatosis

Prospective Multicenter Phase III Trial Using CRS With / Without HIPEC After Preoperative Chemotherapy in Patients With Peritoneal Carcinomatosis of Gastric Cancer Incl. Adenocarcinoma of the Esophagogastric Junction

frequency of toxicity and adverse events, visit 1-11 (every 3 weeks) and thereafter every 3 months up to 2.5 years. AE is documented with the date of the begin and the end of the AE and the intensity according to CTCAE V4.0

frequency of necessary secondary surgical procedures and the length of hospitalisation every 6 months up to 2.5 years . The date of the begin and the end is daocumented as well as the reasons

Overall survival from randomisation up to end of study, follow up every 3 months till 2.5 years

30 days complication-rate. Complications are ranked from grade 0-5 according to CTCAE V4.0

time to progress of tumor, follow up every 3 months till 2.5 years

time to other distant metastases follow up every 3 months till 2.5 years

quality of life (EORTC QLQ-30, STO 22). Every 6 months to 2,5 years

Spots Global Cancer Trial Database for secondary malignant neoplasm of other and unspecified sites