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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


N/A
18 Years
80 Years
Open (Enrolling)
Both
Stomach Neoplasms

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival

Outcome Time Frame:

3-year

Safety Issue:

No

Principal Investigator

Jiren Yu

Investigator Role:

Principal Investigator

Investigator Affiliation:

The First Affiliated Hospital of Medical School of Zhejiang University

Authority:

China: Ethics Committee

Study ID:

ZYYY-GC1105

NCT ID:

NCT01364376

Start Date:

June 2011

Completion Date:

June 2017

Related Keywords:

  • Stomach Neoplasms
  • Gastric Cancer
  • Neoplasms
  • Carcinoma
  • Stomach Neoplasms

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