Neoadjuvant Chemotherapy With SEEOX Regimen for Borrmann Type 4 Gastric Cancer
NCT-B4
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
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2017
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2016
CompletedFirst Posted
Study publicly available on registry
October 31, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedOctober 31, 2016
October 1, 2016
2 years
October 27, 2016
October 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
2-year survival rate
up to 4 years
Secondary Outcomes (4)
Overall response rate
up to 2 years
R0 resection rate
up to 2 years
Operative mortality rate
up to 2 years
in-hospital mortality rate
up to 2 years
Study Arms (1)
SEEOX group
EXPERIMENTALA 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Research institue of general surgery, Jinling hospital
Nanjing, Jiangsu, 210000, China
Related Publications (1)
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.
PMID: 33425441DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Guoli Li, M.D.
Jinlin Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 27, 2016
First Posted
October 31, 2016
Study Start
January 1, 2017
Primary Completion
January 1, 2019
Study Completion
January 1, 2021
Last Updated
October 31, 2016
Record last verified: 2016-10