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

Primary Purpose

Stomach Neoplasms, Gastric Cancer

Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
oxaliplatin
etoposide
pharmorubicin
S-1
Sponsored by
Jinling Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Neoplasms focused on measuring gastric cancer, neoadjuvant chemotherapy, efficacy, safety

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Jinling Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SEEOX group

SOX group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

3 year progression free survival
time period calculated from randomization to the first disease progression, recurrence or death from any cause

Secondary Outcome Measures

Objective response rate
the proportion of patients with complete and partial response according to Response Evaluation Criteria in Solid Tumors guidelines (version 1.1)
R0 resection rate
the proportion of complete tumor resection with no microscopic or macroscopic residual diseases in all operations
3 year overall survival
time period calculated from randomization to death from any cause
Adverse events of preoperative chemotherapy
preoperative chemotherapy associated complications

Full Information

First Posted
October 15, 2014
Last Updated
September 27, 2023
Sponsor
Jinling Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT02338518
Brief Title
Comparison of SEEOX and SOX Regimens in Stage ⅢB/ⅢC Gastric Cancer Patients
Acronym
SVOSA
Official Title
Comparison of SEEOX and SOX Chemotherapeutic Regimens in Stage ⅢB/ⅢC Gastric Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 4, 2015 (Actual)
Primary Completion Date
May 21, 2019 (Actual)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinling Hospital, China

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms, Gastric Cancer
Keywords
gastric cancer, neoadjuvant chemotherapy, efficacy, safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
297 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SEEOX group
Arm Type
Experimental
Arm Description
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.
Arm Title
SOX group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Description
etoposide 80 mg/m2 was administered from the celiac artery on day 1 of every cycle in SEEOX group.
Intervention Type
Drug
Intervention Name(s)
pharmorubicin
Other Intervention Name(s)
epirubicin
Intervention Description
pharmorubicin 30 mg/m2 was administered from the celiac artery on day 1 of every cycle in SEEOX group.
Intervention Type
Drug
Intervention Name(s)
S-1
Intervention Description
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.
Primary Outcome Measure Information:
Title
3 year progression free survival
Description
time period calculated from randomization to the first disease progression, recurrence or death from any cause
Time Frame
up to 7 years
Secondary Outcome Measure Information:
Title
Objective response rate
Description
the proportion of patients with complete and partial response according to Response Evaluation Criteria in Solid Tumors guidelines (version 1.1)
Time Frame
up to 4 years
Title
R0 resection rate
Description
the proportion of complete tumor resection with no microscopic or macroscopic residual diseases in all operations
Time Frame
up to 4 years
Title
3 year overall survival
Description
time period calculated from randomization to death from any cause
Time Frame
up to 7 years
Title
Adverse events of preoperative chemotherapy
Description
preoperative chemotherapy associated complications
Time Frame
up to 4 years
Other Pre-specified Outcome Measures:
Title
Sensitivity analysis of primary outcome adjusted for stratification factors
Time Frame
up to 7 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guoli Li, M.D.
Organizational Affiliation
Jinlin Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Jinling Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China

12. IPD Sharing Statement

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

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