Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HIPEC · 1 trial · 3 indications
Overall survival from randomisation up to end of study, follow up every 3 months till 2.5 years
| Arm | Type | Description |
|---|---|---|
| without HIPEC | NO_INTERVENTION | 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. |
| With HIPEC | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| HIPEC | PROCEDURE | 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. |
Inclusion Criteria: * Histological proved diagnosis of peritoneal metastasized gastric cancer including carcinoma of the AEG No evidence of other distant metastases than peritoneal carcinomatosis with exception of Krukenberg Tumors * Peritoneal Staging with laparoscopy (or explorative laparotomy) a...