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Advanced gastric cancer combined with peritoneal seeind has dismal prognosis with poor response to systemic chemotherapy and with rapid aggravation of symptoms such as abdominal pain, ileus, and poor nutritional intake. Intraperitoneal (IP) chemotherapy through IP port or catheter has lower complication than HIPEC (hyperthermic intraperitoneal chemotherapy) and can deliver higher dose of chemotherapy with less systemic toxicity. IP chemotherapy combined with systemic chemotehrapy showed benefit in several clinical trials, despite lack of statistical significance in phase 3 clinical trial. Proper dose/combination of chemotherapeutic agents and indication of IP chemotherapy should be investigated through prospective, large-scale clinical trials.
Conversion surgery after cytotoxic chemotherapy showed improved survival in retrospective studies. Our hypothesis is that IP chemotherapy combined with systemic chemotherpay (capecitabine + oxaliplatin) would improve success rate of conversion surgery with R0 resection. In the present study, the treatment regimen consists of intraperitoneal paclitaxel combined with oxaliplatin and capecitabine (XELOX), and will be performed following surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraperitoneal paclitaxel with systemic chemotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1. Treatment: IP chemotherapy + Systemic chemotherapy | Drug | 1. Treatment: IP chemotherapy + Systemic chemotherapy Day1 + Day 8: IP Paclitaxel 40 mg/m2 every 3 weeks Day1: IV Oxaliplatin 100 mg/m2 every 3 weeks Day 1~14: Capecitabine 1000 mg/m2 PO, BID every 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of R0 resection | Success rate of conversion surgery (Rate of R0 resection) | 30 days after the surgery |
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Inclusion Criteria:
Histologically or cytologically confirmed advanced gastric cancer adenocarcinoma
Peritoneal metastasis histopathologically confirmed by laparoscopy or laparotomy and PCI <12 (including patients with no gross peritoneal lesion and cytology positive)
No prior surgery for curative aim and previous chemotherapy for recurrent/metastatic gastric cancer
Patient who is willing and able to provide written informed consent/assent for the trial
Age between 19 and 75 years
Measurable lesion according to RECIST 1.1 criteria
ECOG performance status 0-1
Have adequate organ function
Should agree to use an adequate method of contraception
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seung Ho Choi, M.D., Ph.D. | Contact | 82-2-2019-3374 | choish@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gangnam Severacne Hospital | Recruiting | Seoul | Gangnnam | South Korea |
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| 2. Response evaluation after 4 cycles of IP + systemic chemotherapy | Procedure | 2. Response evaluation after 4 cycles of IP + systemic chemotherapy
|
|
| ID | Term |
|---|---|
| D010534 | Peritoneal Neoplasms |
| ID | Term |
|---|---|
| D000008 | Abdominal Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D010532 | Peritoneal Diseases |
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