Clinical trial NCT02949258: Neoadjuvant Chemotherapy With SEEOX Regimen for Borrmann Type 4 Gastric Cancer
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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stomach Neoplasms
Gastric Cancer
Keywords: gastric cancer
Borrmann type 4
Neoadjuvant chemotherapy
Intra-arterial administration
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2016-10-31
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 2-year survival rate
timeFrame: up to 4 years
Secondary outcomes:
measure: Overall response rate
timeFrame: up to 2 years
measure: R0 resection rate
timeFrame: up to 2 years
measure: Operative mortality rate
timeFrame: up to 2 years
measure: in-hospital mortality rate
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Research institue of general surgery, Jinling hospital
state: Jiangsu
Study officials:
affiliation: Jinlin Hospital
name: Guoli Li, M.D.
role: STUDY_CHAIR
References:
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.