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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2011 by Zhejiang University
Sponsor:
Information provided by:
Zhejiang University
ClinicalTrials.gov Identifier:
NCT01364376
First received: May 19, 2011
Last updated: June 13, 2011
Last verified: May 2011

May 19, 2011
June 13, 2011
June 2011
June 2017   (final data collection date for primary outcome measure)
overall survival [ Time Frame: 3-year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01364376 on ClinicalTrials.gov Archive Site
  • progression-free survival(PFS) [ Time Frame: 3-year ] [ Designated as safety issue: No ]
  • clinical response [ Time Frame: 6 or 12 weeks ] [ Designated as safety issue: No ]
  • pathological response [ Time Frame: within 10 days after surgery ] [ Designated as safety issue: No ]
  • Number of Participants with grade 3/4 adverse Events [ Time Frame: 6 Years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
S-1 Plus Oxaliplatin Compared With Fluorouracil, Leucovorin Calcium Plus Oxaliplatin as Perioperative Chemotherapy for Advanced Gastric Carcinoma
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Stomach Neoplasms
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

  • Active Comparator: FOLFOX
    Intervention: Drug: S-1; Oxaliplatin; 5-Fu; Leucovorin Calcium
  • Experimental: SOX
    Intervention: Drug: S-1; Oxaliplatin; 5-Fu; Leucovorin Calcium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
583
June 2017
June 2017   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Jiren Yu +86-571-87236147 clinical_trials@163.com
China
 
NCT01364376
ZYYY-GC1105
Not Provided
Jiren Yu, Zhejiang University
Zhejiang University
Not Provided
Principal Investigator: Jiren Yu The First Affiliated Hospital of Medical School of Zhejiang University
Zhejiang University
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP