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S-1 Plus Oxaliplatin Compared With Fluorouracil, Leucovorin Calcium Plus Oxaliplatin as Perioperative Chemotherapy for Advanced Gastric Carcinoma (Focus)

Primary Purpose

Stomach Neoplasms

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
S-1; Oxaliplatin; 5-Fu; Leucovorin Calcium
Sponsored by
Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Neoplasms focused on measuring Gastric Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically confirmed gastric adenocarcinoma,diagnosed as locally advanced gastric cancer and primary tumor invades or penetrates serosa
  • Ambulatory males or females, aged 18-80 years old
  • ECOG score 0-2
  • Given informed consent
  • Life expectancy more than 3 months
  • Measurable lesion
  • Normal cardiac, hepatic, renal, and bone marrow function(WBC:3.5×10^9/l~12×10^9/l;PLT:>100×109/l;Bil:<1.5 fold of upper limit value; ALT/AST:<2.5 fold of upper limit value;Ccr:>80ml/min;Cr:1.5mg/dl)

Exclusion Criteria:

  • Prior stomach surgery
  • Previous cytotoxic chemotherapy, radiotherapy, target therapy or immunotherapy for any tumor
  • History of another malignancy except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
  • distant metastasis(such as No.16 and No.13 lymphnode,liver, lung,brain,bones or peritoneal metastasis)
  • Severe bleeding
  • Bowel obstruction, ileus or complete pyloric obstruction
  • Serious uncontrolled concomitant disease
  • History of myocardial infarction in 6 months
  • Woman with on-going pregnancy or breast-feeding, or contemplating pregnancy
  • Systemic treatment with corticosteroid
  • Patients judged inappropriate for the trial by the physicians

Sites / Locations

  • Qilu Hospital of Shandong University
  • Shandong Provincial Hospital
  • Sir Run Run Shaw Hospital
  • The First Affiliated Hospital of Medical School of Zhejiang University
  • The Second Affiliated Hospital of Medical School of Zhejiang University
  • Jiaxing First Hospital
  • Ningbo Medical Treatment Center Lihuili Hospital
  • The second affiliated hospital of Wenzhou medical college

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

FOLFOX

SOX

Arm Description

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

progression-free survival(PFS)
clinical response
pathological response
Number of Participants with grade 3/4 adverse Events

Full Information

First Posted
May 19, 2011
Last Updated
August 20, 2016
Sponsor
Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT01364376
Brief Title
S-1 Plus Oxaliplatin Compared With Fluorouracil, Leucovorin Calcium Plus Oxaliplatin as Perioperative Chemotherapy for Advanced Gastric Carcinoma
Acronym
Focus
Official Title
S-1 Plus Oxaliplatin Compared With Fluorouracil, Leucovorin Calcium Plus Oxaliplatin as Perioperative Chemotherapy for Advanced Gastric Carcinoma: a Multi-center, Open-labeled, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang University

4. Oversight

5. Study Description

Brief Summary
This is a randomized multicenter controlled study of oxaliplatin, leucovorin calcium , plus 5-fluorouracil (FOLFOX) compared with S-1 plus oxaliplatin (SOX) as perioperative chemotherapy for advanced gastric cancer. Hypothesis: SOX is not inferior to FOLFOX as perioperative chemotherapy for advanced gastric cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms
Keywords
Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
583 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FOLFOX
Arm Type
Active Comparator
Arm Title
SOX
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
S-1; Oxaliplatin; 5-Fu; Leucovorin Calcium
Intervention Description
FOLFOX: oxaliplatin 130mg/m2 on day 1, CF 400mg/m2 on day 1, 5-Fu 400mg/m2 on day 1; 5-FU 2400 mg/m2 46hr civ regimen repeated every 3 weeks Pre-operative chemotherapy: 2-4 cycles and peri-operative chemotherapy consist of 6 cycles SOX: oxaliplatin 130mg/m2 on day 1, S-1 for 14 days regimen repeated every 3 weeks Pre-chemotherapy: 2-4 cycles, totally 6 cycles of perioperative chemotherapy
Primary Outcome Measure Information:
Title
overall survival
Time Frame
3-year
Secondary Outcome Measure Information:
Title
progression-free survival(PFS)
Time Frame
3-year
Title
clinical response
Time Frame
6 or 12 weeks
Title
pathological response
Time Frame
within 10 days after surgery
Title
Number of Participants with grade 3/4 adverse Events
Time Frame
6 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed gastric adenocarcinoma,diagnosed as locally advanced gastric cancer and primary tumor invades or penetrates serosa Ambulatory males or females, aged 18-80 years old ECOG score 0-2 Given informed consent Life expectancy more than 3 months Measurable lesion Normal cardiac, hepatic, renal, and bone marrow function(WBC:3.5×10^9/l~12×10^9/l;PLT:>100×109/l;Bil:<1.5 fold of upper limit value; ALT/AST:<2.5 fold of upper limit value;Ccr:>80ml/min;Cr:1.5mg/dl) Exclusion Criteria: Prior stomach surgery Previous cytotoxic chemotherapy, radiotherapy, target therapy or immunotherapy for any tumor History of another malignancy except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix distant metastasis(such as No.16 and No.13 lymphnode,liver, lung,brain,bones or peritoneal metastasis) Severe bleeding Bowel obstruction, ileus or complete pyloric obstruction Serious uncontrolled concomitant disease History of myocardial infarction in 6 months Woman with on-going pregnancy or breast-feeding, or contemplating pregnancy Systemic treatment with corticosteroid Patients judged inappropriate for the trial by the physicians
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiren Yu
Organizational Affiliation
The First Affiliated Hospital of Medical School of Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
Country
China
Facility Name
Shandong Provincial Hospital
City
Jinan
State/Province
Shandong
Country
China
Facility Name
Sir Run Run Shaw Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
The First Affiliated Hospital of Medical School of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
The Second Affiliated Hospital of Medical School of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Jiaxing First Hospital
City
Jiaxing
State/Province
Zhejiang
Country
China
Facility Name
Ningbo Medical Treatment Center Lihuili Hospital
City
Ningbo
State/Province
Zhejiang
Country
China
Facility Name
The second affiliated hospital of Wenzhou medical college
City
Wenzhou
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
35226081
Citation
Yu J, Gao Y, Chen L, Wu D, Shen Q, Zhao Z, Liu W, Yang H, Zhang Q, Wang X, Hu P, Zheng Z, Wang X, Liu H, Xu Z, Yan Z, Wu Y, Jin M, Zhang Q, Liu X, Zhu K, Shou C. Effect of S-1 Plus Oxaliplatin Compared With Fluorouracil, Leucovorin Plus Oxaliplatin as Perioperative Chemotherapy for Locally Advanced, Resectable Gastric Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2022 Feb 1;5(2):e220426. doi: 10.1001/jamanetworkopen.2022.0426.
Results Reference
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S-1 Plus Oxaliplatin Compared With Fluorouracil, Leucovorin Calcium Plus Oxaliplatin as Perioperative Chemotherapy for Advanced Gastric Carcinoma

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