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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

583 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2016-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Stomach Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FOLFOX

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

SOX

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Interventions

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

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No