A Phase 2 interventional study of oxaliplatin and etoposide in Stomach Neoplasms and Gastric Cancer, sponsored by Jinling Hospital, China. Status unknown at 1 site in China. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-10-31.
Sponsored by Jinling Hospital, China · Phase 2, Interventional, and Treatment
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.
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.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's planned enrollment of 40 is below the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Jinling Hospital, China is the lead sponsor of 126 studies on the registry; 34 are open to participants now.
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A three-cycle neoadjuvant chemotherapy will be performed in all cases. In every cycle, oxaliplatin 150 mg, etoposide 100 mg and epirubicin 50 mg will be administered from the celiac artery on day 1. Oral S-1 120 mg per day will be given for days 1-14. The second cycle will be scheduled following a 1-week rest after the first cycle.After two courses of neoadjuvant chemotherapy, patients will be reevaluated and receive curative or palliative resection or exploratory laparotomy within 14 days after completing the second course of chemotherapy.
Drug: oxaliplatin · Drug: etoposide · Drug: epirubicin · Drug: S1
oxaliplatin 150 mg will be administered from the celiac artery on day 1 of every cycle in all cases
etoposide 100 mg will be administered from the celiac artery on day 1 of every cycle in all cases
epirubicin 30 mg will be administered from the celiac artery on day 1 of every cycle in all cases
Oral S-1 120 mg per day will be administered on days 1-14 of every cycle in all cases
2-year survival rate
Time frame: up to 4 years
Overall response rate
Time frame: up to 2 years
R0 resection rate
Time frame: up to 2 years
Operative mortality rate
Time frame: up to 2 years
in-hospital mortality rate
Time frame: up to 2 years
This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Jinling Hospital, China