Neoadjuvant Chemotherapy With SEEOX Regimen for Borrmann Type 4 Gastric Cancer

Gastric Cancer Clinical Trial

— NCT-B4  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02949258
• Other study ID #: B4-2016-LGL
• Status: Not yet recruiting
• Phase: Phase 2
• First received: October 27, 2016
• Last updated: October 27, 2016
• Start date: January 2017
• Est. completion date: January 2021

Study information

• Verified date: October 2016
• Source: Jinling Hospital, China
• Contact: Qi He, M.D., PhD.
• Phone: +86-13851490577
• Email: 241549864[@]qq.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 2021
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

Inclusion Criteria:

• histologically confirmed gastric adenocarcinoma;

• males or females, aged 30-70 years;

• gastroscopy and abdominal computed tomography (CT) scan-confirmed typical scirrhous gastric cancer (without definitive ulceration) that invaded more than half of the stomach;

• no peritoneal metastasis confirmed by laparoscopic exploration and with cytological examination of peritoneal washing of the Douglas pouch;

• eastern Cooperative Oncology Group performance status of 0 or 1;

• no serious concomitant diseases that make survival period < 3 years;

• no prior anti-tumor therapy;

• have signed informed consent before the beginning of treatment.

Exclusion Criteria:

• patients can not bear surgical procedure;

• pregnant or lactating women;

• previous cytotoxic chemotherapy, radiotherapy or immunotherapy;

• with peritoneal metastasis or distant metastasis;

• history of another malignancy within the last five years;

• history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the Investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake;

• clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication or myocardial infarction within the last 12 months;

• organ allografts requiring immunosuppressive therapy;

• serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease;

• moderate or severe renal impairment: serum creatinine > 1.5 x upper limit of normal (ULN);

• hypersensitivity to any drug of the study regimen;

• unwilling or unable to comply with the protocol for the duration of the study.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Research institue of general surgery, Jinling hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jinling Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-year survival rate		up to 4 years	Yes
Secondary	Overall response rate		up to 2 years	Yes
Secondary	R0 resection rate		up to 2 years	Yes
Secondary	Operative mortality rate		up to 2 years	Yes
Secondary	in-hospital mortality rate		up to 2 years	Yes