NCT02949258

Neoadjuvant Chemotherapy With SEEOX Regimen for Borrmann Type 4 Gastric Cancer

A Phase II Study of Neoadjuvant Chemotherapy With SEEOX Regimen Via Intra-arterial and Intravenous Administration Followed by Surgery for Borrmann Type 4 Gastric Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Jinling Hospital, China · Academic / Other
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Scirrhous gastric cancer, also known as linitis plastic or Borrmann type 4, is an aggressive tumor with an extremely poor prognosis. Aggressive surgical procedures and adjuvant chemotherapies have not improved the survival rate. The purpose of this study is to determine whether neoadjuvant Chemotherapy with SEEOX regimen via intra-arterial and intravenous administration are effective in the treatment of Borrmann type 4 gastric cancer.

Detailed description

Gastric cancer patients who diagnosed as Borrmann type 4 would be included in this study.They would receive 3 cycles of neoadjuvant chemotherapy with SEEOX regimen via combined intra-arterial and intravenous administration. The treatment schedule consisted of 3 courses (each, 2-week administration and 1-week withdrawal) of intra-arterial administration of oxaliplatin (150mg), etoposide (100mg) and epirubicin(30mg) by Seldinger method on day 1 and oral S-1(120mg) on days 1-14, followed by radical surgery.The efficacy and toxicity of SEEOX regimen would be examined.

Conditions

• Stomach Neoplasms
• Gastric Cancer

Interventions

Type	Name	Description
DRUG	oxaliplatin	oxaliplatin 150 mg will be administered from the celiac artery on day 1 of every cycle in all cases
DRUG	etoposide	etoposide 100 mg will be administered from the celiac artery on day 1 of every cycle in all cases
DRUG	epirubicin	epirubicin 30 mg will be administered from the celiac artery on day 1 of every cycle in all cases
DRUG	S1	Oral S-1 120 mg per day will be administered on days 1-14 of every cycle in all cases

Timeline

• Start date: 2017-01-01
• Primary completion: 2019-01-01
• Completion: 2021-01-01
• First posted: 2016-10-31
• Last updated: 2016-10-31

Locations

1 site across 1 country: China