NCT02845908

POF Versus FOLFOX Versus FOLFOX Plus ip Paclitaxel in AGC

A Phase 2 Study of POF(Paclitaxel/Oxaliplatin/5-Fluorouracil/Leucovorin) Versus FOLFOX Versus FOLFOX Plus Intraperitoneal Paclitaxel as a First-line Treatment in Advanced Gastric Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study was to compare the efficacy and safety of POF, FOLFOX, and FOLFOX plus paclitaxel(ip) as first-line treatment in AGC a phase II clinical trial.

Detailed description

The biweekly 5-fluorouracil and leucovorin (LV5FU2) regimen associated with oxaliplatin (FOLFOX) is active in patients with AGC. Meanwhile, Paclitaxel monotherapy is also active in patients with AGC. In previous studies, we found that POF(A combination of oxaliplatin, fluorouracil and Paclitaxel) regimen appears to be of good efficacy and is well tolerated in patients with advanced gastric cancer. This study is being done to find out if three drugs combination maintain manageable side effects but have better benefit than two drugs combination. Intraperitoneal paclitaxel showed high local concentration in abdominal cavity and low systemic toxicity. This study is being done to find out if the combination with Intraperitoneal paclitaxel and FOLFOX have higher local control rate and lower systemic toxicity.

Conditions

• Malignant Neoplasm of Stomach Stage IV

Interventions

Type	Name	Description
DRUG	POF	Paclitaxel plus Oxaliplatin plus Leucovorin plus 5-FU
DRUG	FOLFOX	Oxaliplatin plus Leucovorin plus 5-FU
DRUG	FOLFOX plus PAC(ip)	FOLFOX plus intraperitoneally PAC

Timeline

• Start date: 2015-11-01
• Primary completion: 2018-05-01
• Completion: 2020-05-01
• First posted: 2016-07-27
• Last updated: 2021-04-23

Locations

1 site across 1 country: China