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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jiren Yu, Zhejiang University
ClinicalTrials.gov Identifier:
NCT01364376
First received: May 19, 2011
Last updated: August 20, 2016
Last verified: August 2016
  Purpose

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.


Condition Intervention
Stomach Neoplasms
Drug: S-1; Oxaliplatin; 5-Fu; Leucovorin Calcium

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

Resource links provided by NLM:


Further study details as provided by Zhejiang University:

Primary Outcome Measures:
  • overall survival [ Time Frame: 3-year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 583
Study Start Date: June 2011
Study Completion Date: August 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: FOLFOX 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

Experimental: SOX 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


  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01364376

Locations
China, Shandong
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shandong Provincial Hospital
Jinan, Shandong, China
China, Zhejiang
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
Ningbo Medical Treatment Center Lihuili Hospital
Ningbo, Zhejiang, China
The second affiliated hospital of Wenzhou medical college
Wenzhou, Zhejiang, China
Sponsors and Collaborators
Zhejiang University
Investigators
Principal Investigator: Jiren Yu The First Affiliated Hospital of Medical School of Zhejiang University
  More Information

Responsible Party: Jiren Yu, Chief doctor, Zhejiang University
ClinicalTrials.gov Identifier: NCT01364376     History of Changes
Other Study ID Numbers: ZYYY-GC1105 
Study First Received: May 19, 2011
Last Updated: August 20, 2016
Health Authority: China: Ethics Committee

Keywords provided by Zhejiang University:
Gastric Cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Calcium, Dietary
Oxaliplatin
Fluorouracil
Levoleucovorin
Leucovorin
Bone Density Conservation Agents
Physiological Effects of Drugs
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on August 23, 2016