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

Stomach Neoplasms Clinical Trial

— Focus  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01364376
• Other study ID #: ZYYY-GC1105
• Status: Completed
• Phase: N/A
• First received: May 19, 2011
• Last updated: August 20, 2016
• Start date: June 2011
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 583
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Stomach Neoplasms

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Sir Run Run Shaw Hospital	Hangzhou	Zhejiang
China	The First Affiliated Hospital of Medical School of Zhejiang University	Hangzhou	Zhejiang
China	The Second Affiliated Hospital of Medical School of Zhejiang University	Hangzhou	Zhejiang
China	Jiaxing First Hospital	Jiaxing	Zhejiang
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	Shandong Provincial Hospital	Jinan	Shandong
China	Ningbo Medical Treatment Center Lihuili Hospital	Ningbo	Zhejiang
China	The second affiliated hospital of Wenzhou medical college	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		3-year	No
Secondary	progression-free survival(PFS)		3-year	No
Secondary	clinical response		6 or 12 weeks	No
Secondary	pathological response		within 10 days after surgery	No
Secondary	Number of Participants with grade 3/4 adverse Events		6 Years	Yes