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

Zhejiang University

Status

Completed

Conditions

Stomach Neoplasms

Treatments

Drug: S-1; Oxaliplatin; 5-Fu; Leucovorin Calcium

Study type

Interventional

Funder types

Other

Identifiers

NCT01364376

ZYYY-GC1105

Details and patient eligibility

About

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.

Enrollment

583 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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