NCT04797923

A Phase II Study of Conversion Surgery After IP Paclitaxel With XELOX Chemotherapy in AGC With Peritoneal Dissemination

A Phase II Study Evaluating Efficacy and Safety of Conversion Surgery After Intraperitoneal Paclitaxel in Combination With Systemic Capecitabine and Oxaliplatin Chemotherapy in Advanced Gastric Cancer Patients With Peritoneal Dissemination

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: Gangnam Severance Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Advanced Gastric Cancer
• Peritoneal Carcinomatosis

Interventions

Type	Name	Description
DRUG	1. Treatment: IP chemotherapy + Systemic chemotherapy	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
PROCEDURE	2. Response evaluation after 4 cycles of IP + systemic chemotherapy	2\. Response evaluation after 4 cycles of IP + systemic chemotherapy * Conversion surgery will be done following diagnostic laparoscopy after 4 cycles of IP + systemic chemotherapy. Additional 4 cycles of IP + systemic chemotherapy wille be done following surgery. * If surgery is impossible after 4th cycle, four additional cycles of treatment will be done, and convertibility will be evaluated. * IP chemotherapy should not exceed total of 8 cycles.

Timeline

• Start date: 2019-12-01
• Primary completion: 2021-06-30
• Completion: 2021-12-30
• First posted: 2021-03-15
• Last updated: 2021-03-15

Locations

1 site across 1 country: South Korea