Neoadjuvant Chemotherapy With SEEOX Regimen for Borrmann Type 4 Gastric Cancer (NCT-B4)

October 27, 2016 updated by: Li Guoli, Jinling Hospital, China

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Xulin Wang, M.D., PhD.
  • Phone Number: +86-18900672829
  • Email: 48651569@qq.com

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Research institue of general surgery, Jinling hospital
        • Contact:
          • Guoli Li, M.D.
          • Phone Number: +86-13851559752

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SEEOX group
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
2-year survival rate
Time Frame: up to 4 years
up to 4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall response rate
Time Frame: up to 2 years
up to 2 years
R0 resection rate
Time Frame: up to 2 years
up to 2 years
Operative mortality rate
Time Frame: up to 2 years
up to 2 years
in-hospital mortality rate
Time Frame: up to 2 years
up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jinling Hospital, China

Investigators

  • Study Chair: Guoli Li, M.D., Jinlin Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

January 1, 2021

Study Registration Dates

First Submitted

October 27, 2016

First Submitted That Met QC Criteria

October 27, 2016

First Posted (Estimate)

October 31, 2016

Study Record Updates

Last Update Posted (Estimate)

October 31, 2016

Last Update Submitted That Met QC Criteria

October 27, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B4-2016-LGL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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