S-1 Plus Oxaliplatin Compared With Fluorouracil, Leucovorin Calcium Plus Oxaliplatin as Perioperative Chemotherapy for Advanced Gastric Carcinoma
Focus
1 other identifier
interventional
583
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2011
Longer than P75 for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedFirst Posted
Study publicly available on registry
June 2, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedAugust 23, 2016
August 1, 2016
5.2 years
May 19, 2011
August 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall survival
3-year
Secondary Outcomes (4)
progression-free survival(PFS)
3-year
clinical response
6 or 12 weeks
pathological response
within 10 days after surgery
Number of Participants with grade 3/4 adverse Events
6 Years
Study Arms (2)
FOLFOX
ACTIVE COMPARATORSOX
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shandong Provincial Hospital
Jinan, Shandong, China
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Medical School of Zhejiang University
Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Medical School of Zhejiang University
Hangzhou, Zhejiang, China
Jiaxing First Hospital
Jiaxing, Zhejiang, China
Ningbo Medical Treatment Center Lihuili Hospital
Ningbo, Zhejiang, China
The second affiliated hospital of Wenzhou medical college
Wenzhou, Zhejiang, China
Related Publications (1)
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.
PMID: 35226081DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jiren Yu
The First Affiliated Hospital of Medical School of Zhejiang University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief doctor
Study Record Dates
First Submitted
May 19, 2011
First Posted
June 2, 2011
Study Start
June 1, 2011
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
August 23, 2016
Record last verified: 2016-08