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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stomach Neoplasms; Gastric Cancer
• Intervention / Treatment: Drug: oxaliplatin; Drug: etoposide; Drug: pharmorubicin; Drug: S-1

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.

• Study Type: Interventional
• Enrollment (Actual): 297
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210002
      • Jinling Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SEEOX group; A three-cycle neo-adjuvant chemotherapy was performed in all cases. In every cycle, oxaliplatin 100 mg/m2, etoposide 80 mg/m2, and pharmorubicin 30 mg/m2 were administered from the celiac artery on day 1. 80～120 mg of oral S-1 per square meter of body-surface area per day was given for 2 weeks. The second cycle was scheduled following a 1-week rest after the first cycle.	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.; Drug: etoposide; etoposide 80 mg/m2 was administered from the celiac artery on day 1 of every cycle in SEEOX group.; Drug: pharmorubicin; pharmorubicin 30 mg/m2 was administered from the celiac artery on day 1 of every cycle in SEEOX group.; Other Names: epirubicin; Drug: 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.
Active Comparator: SOX group; A three-cycle neo-adjuvant chemotherapy was performed in all cases. In every cycle, patients received intravenous oxaliplatin 130 mg/m2 on day 1, and 80~120 mg of oral S-1 per square meter of body-surface area per day was given for 2 weeks. The second cycle was scheduled following a 1-week rest after the first cycle.	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.; Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
R0 resection rate	the proportion of complete tumor resection with no microscopic or macroscopic residual diseases in all operations	up to 4 years
3 year overall survival	time period calculated from randomization to death from any cause	up to 7 years
Adverse events of preoperative chemotherapy	preoperative chemotherapy associated complications	up to 4 years

Other Outcome Measures

Outcome Measure	Time Frame
Sensitivity analysis of primary outcome adjusted for stratification factors	up to 7 years

Collaborators and Investigators

• Sponsor: Jinling Hospital, China
• Investigators: Study Chair: Guoli Li, M.D., Jinlin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2015
• Primary Completion (Actual): May 21, 2019
• Study Completion (Estimated): October 1, 2023

Study Registration Dates

• First Submitted: October 15, 2014
• First Submitted That Met QC Criteria: January 9, 2015
• First Posted (Estimated): January 14, 2015

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: safety; neoadjuvant chemotherapy; efficacy; gastric cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Etoposide; Epirubicin; Oxaliplatin
• Other Study ID Numbers: 20140621; 08Z28 (Other Grant/Funding Number: Nanjing Military Region)