NCT02338518

Comparison of SEEOX and SOX Regimens in Stage ⅢB/ⅢC Gastric Cancer Patients

Comparison of SEEOX and SOX Chemotherapeutic Regimens in Stage ⅢB/ⅢC Gastric Cancer Patients

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 297 (actual)
• Sponsor: Jinling Hospital, China · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Chemotherapy is an important therapeutic method for patients with advanced gastric cancer. However, there is currently no established standard chemotherapeutic regimen in the preoperative or neoadjuvant treatment setting. The aim of our study was to compare the efficacy and toxicity between SEEOX and SOX regimens. The investigators estimate that combined intravenous and intra-arterial intensified SEEOX preoperative chemotherapy may be a safe and promising regimen for locally advanced or initially unresectable gastric cancer patients.

Detailed description

Gastric cancer patients who will receive neoadjuvant chemotherapy would be included in this study. They would receive combined intravenous and intra-arterial intensified SEEOX neoadjuvant chemotherapy or SOX regimen at random. The efficacy and toxicity of these two regimens would be compared.

Conditions

• Stomach Neoplasms
• Gastric Cancer

Interventions

Type	Name	Description
DRUG	oxaliplatin	oxaliplatin 100 mg/m2 was administered from the celiac artery on day 1 of every cycle in SEEOX group and SOX group. Intravenous oxaliplatin 130 mg/m2 was administered on day 1 of every cycle in SOX group.
DRUG	etoposide	etoposide 80 mg/m2 was administered from the celiac artery on day 1 of every cycle in SEEOX group.
DRUG	pharmorubicin	pharmorubicin 30 mg/m2 was administered from the celiac artery on day 1 of every cycle in SEEOX group.
DRUG	S-1	80\~120 mg of oral S-1 per square meter of body-surface area per day was given for 2 weeks in both SEEOX and SOX groups.

Timeline

• Start date: 2015-01-04
• Primary completion: 2019-05-21
• Completion: 2023-10-01
• First posted: 2015-01-14
• Last updated: 2023-09-29

Locations

1 site across 1 country: China