Comparison of SEEOX and SOX Regimens in Stage ⅢB/ⅢC Gastric Cancer Patients

Gastric Cancer Clinical Trial

— SVOSA  

Official title:

Comparison of SEEOX and SOX Chemotherapeutic Regimens in Stage ⅢB/ⅢC Gastric Cancer Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02338518
• Other study ID #: 20140621
• Secondary ID: 08Z28
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 4, 2015
• Est. completion date: October 2023

Study information

• Verified date: September 2023
• Source: Jinling Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 297
• Est. completion date: October 2023
• Est. primary completion date: May 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• oxaliplatin
oxaliplatin 100 mg/m2 was administered from the celiac artery on day 1 of every cycle in SEEOX group and SOX group. Intravenous oxaliplatin 130 mg/m2 was administered on day 1 of every cycle in SOX group.
• etoposide
etoposide 80 mg/m2 was administered from the celiac artery on day 1 of every cycle in SEEOX group.
• pharmorubicin
pharmorubicin 30 mg/m2 was administered from the celiac artery on day 1 of every cycle in SEEOX group.
• S-1
80~120 mg of oral S-1 per square meter of body-surface area per day was given for 2 weeks in both SEEOX and SOX groups.

Locations

Country	Name	City	State
China	Jinling Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jinling Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sensitivity analysis of primary outcome adjusted for stratification factors		up to 7 years
Primary	3 year progression free survival	time period calculated from randomization to the first disease progression, recurrence or death from any cause	up to 7 years
Secondary	Objective response rate	the proportion of patients with complete and partial response according to Response Evaluation Criteria in Solid Tumors guidelines (version 1.1)	up to 4 years
Secondary	R0 resection rate	the proportion of complete tumor resection with no microscopic or macroscopic residual diseases in all operations	up to 4 years
Secondary	3 year overall survival	time period calculated from randomization to death from any cause	up to 7 years
Secondary	Adverse events of preoperative chemotherapy	preoperative chemotherapy associated complications	up to 4 years