S-1 Plus Oxaliplatin Compared With Fluorouracil, Leucovorin Calcium Plus Oxaliplatin as Perioperative Chemotherapy for Advanced Gastric Carcinoma
Conditions
Stomach Neoplasms
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
Gastric Cancer
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: S-1; Oxaliplatin; 5-Fu; Leucovorin Calcium
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Both
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
Locations
Qilu Hospital of Shandong University
Jinan, Shandong, China
Status: Not yet recruiting
Contact: Dai Yong - yong_dai@163.com
Shandong cancer hospital
Jinan, Shandong, China
Status: Not yet recruiting
Contact: Heng Ma - rct_sd_cancer@163.com
Shandong Provincial Hospital
Jinan, Shandong, China
Status: Not yet recruiting
Contact: Hongjun liu - liuhongjun502@hotmail.com
The Affiliated hospital of Medical college Qingdao University
Qingdao, Shandong, China
Status: Not yet recruiting
Contact: Yanbing Zhou - zhouyanbing999@yahoo.com.cn
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China
Status: Not yet recruiting
Contact: Linbo Wang - wanglinbo@medmail.com.cn
The First Affiliated Hospital of Medical School of Zhejiang University
Hangzhou, Zhejiang, China
Status: Recruiting
Contact: Jiren yu - clinical_trials@163.com
The Second Affiliated Hospital of Medical School of Zhejiang University
Hangzhou, Zhejiang, China
Status: Not yet recruiting
Contact: Li Chen - chenli@mail.hz.zj.cn
Jiaxing First Hospital
Jiaxing, Zhejiang, China
Status: Not yet recruiting
Contact: Honggang Jiang - jianghg65@126.com
Ningbo Medical Treatment Center Lihuili Hospital
Ningbo, Zhejiang, China
Status: Not yet recruiting
Contact: Zhilong Yan - zlongyan@126.com
Yinzhou People's Hospital
Ningbo, Zhejiang, China
Status: Not yet recruiting
Contact: Yingjie Wu - rct_nbyzyy@163.com
Taizhou hospital
Taizhou, Zhejiang, China
Status: Not yet recruiting
Contact: Tienan Bi - Biranwang@126.com
The second affiliated hospital of Wenzhou medical college
Wenzhou, Zhejiang, China
Status: Not yet recruiting
Contact: Zhiqiang Zhen - zhen_zhi2000@yahoo.com.cn
Start Date
June 2011
Completion Date
June 2017
Sponsors
Zhejiang University
Source
Zhejiang University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page