Clinical trial NCT02338518: Comparison of SEEOX and SOX Regimens in Stage ⅢB/ⅢC Gastric Cancer Patients
Official title: Comparison of SEEOX and SOX Chemotherapeutic Regimens in Stage ⅢB/ⅢC Gastric Cancer Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Stomach Neoplasms
Gastric Cancer
Keywords: gastric cancer
neoadjuvant chemotherapy
efficacy
safety
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2015-01-14
Enrollment: 297
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chemotherapy is an important therapeutic method for patients with advanced gastric cancer. However, there is currently no established standard chemotherapeutic regimen in the preoperative or neoadjuvant treatment setting. The aim of our study was to compare the efficacy and toxicity between SEEOX and SOX regimens. The investigators estimate that combined intravenous and intra-arterial intensified SEEOX preoperative chemotherapy may be a safe and promising regimen for locally advanced or initially unresectable gastric cancer patients.

Detailed description: Gastric cancer patients who will receive neoadjuvant chemotherapy would be included in this study. They would receive combined intravenous and intra-arterial intensified SEEOX neoadjuvant chemotherapy or SOX regimen at random. The efficacy and toxicity of these two regimens would be compared.

Eligibility criteria: Inclusion Criteria:

* Eastern Cooperative Oncology Group(ECOG) score 0-2
* Ambulatory males or females, aged 30-70 years.
* Unresectable gastric cancer (Tumors with bulky nodal metastases surrounding the celiac artery and its branches or invasion of adjacent structures such as pancreas, omentum, esophagus, and aorta were considered unresectable)
* Life expectancy more than 3 months
* Give written informed consent, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
* Normal hepatic, renal, and bone marrow function (GPT\<2 fold of upper limit value; white blood cell count\>4000/dl, Tbil\<1.5mg/dl, Cr\<1.5 fold of upper limit value)

Exclusion Criteria:

* Patients can not bear surgical procedure.
* Pregnant or lactating women.
* Previous cytotoxic chemotherapy, radiotherapy or immunotherapy.
* 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.
* With abdominal cavity implantation metastasis or distant metastasis.
* Unwilling or unable to comply with the protocol for the duration of the study.

Primary outcomes:
measure: 3 year progression free survival
timeFrame: up to 7 years
Secondary outcomes:
measure: Objective response rate
timeFrame: up to 4 years
measure: R0 resection rate
timeFrame: up to 4 years
measure: 3 year overall survival
timeFrame: up to 7 years
measure: Adverse events of preoperative chemotherapy
timeFrame: up to 4 years
Other outcomes:
measure: Sensitivity analysis of primary outcome adjusted for stratification factors
timeFrame: up to 7 years
Locations:
city: Nanjing
country: China
facility: Jinling Hospital
state: Jiangsu
Study officials:
affiliation: Jinlin Hospital
name: Guoli Li, M.D.
role: STUDY_CHAIR
References: