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Neoadjuvant Chemotherapy With SEEOX Regimen for Borrmann Type 4 Gastric Cancer

NCT ID: NCT02949258

Last Updated: 2016-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2021-01-31

Brief Summary

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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

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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.

Conditions

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Stomach Neoplasms Gastric Cancer

Keywords

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gastric cancer Borrmann type 4 Neoadjuvant chemotherapy Intra-arterial administration

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

oxaliplatin

Intervention Type DRUG

oxaliplatin 150 mg will be administered from the celiac artery on day 1 of every cycle in all cases

etoposide

Intervention Type DRUG

etoposide 100 mg will be administered from the celiac artery on day 1 of every cycle in all cases

epirubicin

Intervention Type DRUG

epirubicin 30 mg will be administered from the celiac artery on day 1 of every cycle in all cases

S1

Intervention Type DRUG

Oral S-1 120 mg per day will be administered on days 1-14 of every cycle in all cases

Interventions

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oxaliplatin

oxaliplatin 150 mg will be administered from the celiac artery on day 1 of every cycle in all cases

Intervention Type DRUG

etoposide

etoposide 100 mg will be administered from the celiac artery on day 1 of every cycle in all cases

Intervention Type DRUG

epirubicin

epirubicin 30 mg will be administered from the celiac artery on day 1 of every cycle in all cases

Intervention Type DRUG

S1

Oral S-1 120 mg per day will be administered on days 1-14 of every cycle in all cases

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jinling Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Li Guoli

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guoli Li, M.D.

Role: STUDY_CHAIR

Jinlin Hospital

Locations

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Research institue of general surgery, Jinling hospital

Nanjing, Jiangsu, China

Site Status

Countries

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China

Central Contacts

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Qi He, M.D., PhD.

Role: CONTACT

Phone: +86-13851490577

Email: [email protected]

Xulin Wang, M.D., PhD.

Role: CONTACT

Phone: +86-18900672829

Email: [email protected]

Facility Contacts

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Guoli Li, M.D.

Role: primary

References

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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.

Reference Type DERIVED
PMID: 33425441 (View on PubMed)

Other Identifiers

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B4-2016-LGL

Identifier Type: -

Identifier Source: org_study_id