Clinical trial NCT01364376: S-1 Plus Oxaliplatin Compared With Fluorouracil, Leucovorin Calcium Plus Oxaliplatin as Perioperative Chemotherapy for Advanced Gastric Carcinoma
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
Overall status: COMPLETED
Phase: NA
Conditions: Stomach Neoplasms
Keywords: Gastric Cancer
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2011-06-02
Enrollment: 583
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: overall survival
timeFrame: 3-year
Secondary outcomes:
measure: progression-free survival(PFS)
timeFrame: 3-year
measure: clinical response
timeFrame: 6 or 12 weeks
measure: pathological response
timeFrame: within 10 days after surgery
measure: Number of Participants with grade 3/4 adverse Events
timeFrame: 6 Years
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Medical School of Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Medical School of Zhejiang University
state: Zhejiang
city: Jiaxing
country: China
facility: Jiaxing First Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo Medical Treatment Center Lihuili Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The second affiliated hospital of Wenzhou medical college
state: Zhejiang
Study officials:
affiliation: The First Affiliated Hospital of Medical School of Zhejiang University
name: Jiren Yu
role: PRINCIPAL_INVESTIGATOR
References:
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.