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

Primary Purpose

Stomach Neoplasms, Gastric Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
oxaliplatin
etoposide
epirubicin
S1
Sponsored by
Jinling Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Neoplasms focused on measuring gastric cancer, Borrmann type 4, Neoadjuvant chemotherapy, Intra-arterial administration

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Research institue of general surgery, Jinling hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SEEOX group

Arm Description

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.

Outcomes

Primary Outcome Measures

2-year survival rate

Secondary Outcome Measures

Overall response rate
R0 resection rate
Operative mortality rate
in-hospital mortality rate

Full Information

First Posted
October 27, 2016
Last Updated
October 27, 2016
Sponsor
Jinling Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT02949258
Brief Title
Neoadjuvant Chemotherapy With SEEOX Regimen for Borrmann Type 4 Gastric Cancer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
January 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinling Hospital, China

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms, Gastric Cancer
Keywords
gastric cancer, Borrmann type 4, Neoadjuvant chemotherapy, Intra-arterial administration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SEEOX group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Intervention Description
oxaliplatin 150 mg will be administered from the celiac artery on day 1 of every cycle in all cases
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Description
etoposide 100 mg will be administered from the celiac artery on day 1 of every cycle in all cases
Intervention Type
Drug
Intervention Name(s)
epirubicin
Intervention Description
epirubicin 30 mg will be administered from the celiac artery on day 1 of every cycle in all cases
Intervention Type
Drug
Intervention Name(s)
S1
Intervention Description
Oral S-1 120 mg per day will be administered on days 1-14 of every cycle in all cases
Primary Outcome Measure Information:
Title
2-year survival rate
Time Frame
up to 4 years
Secondary Outcome Measure Information:
Title
Overall response rate
Time Frame
up to 2 years
Title
R0 resection rate
Time Frame
up to 2 years
Title
Operative mortality rate
Time Frame
up to 2 years
Title
in-hospital mortality rate
Time Frame
up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qi He, M.D., PhD.
Phone
+86-13851490577
Email
241549864@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xulin Wang, M.D., PhD.
Phone
+86-18900672829
Email
48651569@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guoli Li, M.D.
Organizational Affiliation
Jinlin Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Research institue of general surgery, Jinling hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guoli Li, M.D.
Phone
+86-13851559752

12. IPD Sharing Statement

Citations:
PubMed Identifier
33425441
Citation
Xiang XS, Su Y, Li GL, Ma L, Zhou CS, Ma RF. Phase II Study of Preoperative Intra-Arterial Epirubicin, Etoposide, and Oxaliplatin Combined with Oral S-1 Chemotherapy for the Treatment of Borrmann Type 4 Gastric Cancer. J Gastric Cancer. 2020 Dec;20(4):395-407. doi: 10.5230/jgc.2020.20.e40. Epub 2020 Dec 29.
Results Reference
derived

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Neoadjuvant Chemotherapy With SEEOX Regimen for Borrmann Type 4 Gastric Cancer

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