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: July 29, 2014
Last verified: May 2011
  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 ]

Estimated Enrollment: 583
Study Start Date: June 2011
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (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
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

Contacts
Contact: Jiren Yu +86-571-87236147 clinical_trials@163.com

Locations
China, Shandong
Shandong Provincial Hospital Not yet recruiting
Jinan, Shandong, China
Contact: Hongjun liu       liuhongjun502@hotmail.com   
Sub-Investigator: Hongjun Liu         
Qilu Hospital of Shandong University Not yet recruiting
Jinan, Shandong, China
Contact: Dai Yong       yong_dai@163.com   
Sub-Investigator: Qingsi He         
Shandong cancer hospital Not yet recruiting
Jinan, Shandong, China
Contact: Heng Ma       rct_sd_cancer@163.com   
Sub-Investigator: Heng Ma         
The Affiliated hospital of Medical college Qingdao University Not yet recruiting
Qingdao, Shandong, China
Contact: Yanbing Zhou       zhouyanbing999@yahoo.com.cn   
Sub-Investigator: Yanbing Zhou         
China, Zhejiang
The Second Affiliated Hospital of Medical School of Zhejiang University Not yet recruiting
Hangzhou, Zhejiang, China
Contact: Li Chen       chenli@mail.hz.zj.cn   
Sub-Investigator: Li Chen         
The First Affiliated Hospital of Medical School of Zhejiang University Recruiting
Hangzhou, Zhejiang, China
Contact: Jiren yu       clinical_trials@163.com   
Principal Investigator: Jiren Yu         
Sir Run Run Shaw Hospital Not yet recruiting
Hangzhou, Zhejiang, China
Contact: Linbo Wang       wanglinbo@medmail.com.cn   
Sub-Investigator: Linbo Wang         
Jiaxing First Hospital Not yet recruiting
Jiaxing, Zhejiang, China
Contact: Honggang Jiang       jianghg65@126.com   
Sub-Investigator: Honggang Jiang         
Ningbo Medical Treatment Center Lihuili Hospital Not yet recruiting
Ningbo, Zhejiang, China
Contact: Zhilong Yan       zlongyan@126.com   
Sub-Investigator: Zhilong Yan         
Yinzhou People's Hospital Not yet recruiting
Ningbo, Zhejiang, China
Contact: Yingjie Wu       rct_nbyzyy@163.com   
Sub-Investigator: Yingjie Wu         
Taizhou hospital Not yet recruiting
Taizhou, Zhejiang, China
Contact: Tienan Bi       Biranwang@126.com   
Sub-Investigator: Tienan Bi         
The second affiliated hospital of Wenzhou medical college Not yet recruiting
Wenzhou, Zhejiang, China
Contact: Zhiqiang Zhen       zhen_zhi2000@yahoo.com.cn   
Sub-Investigator: Zhiqiang Zhen         
Sponsors and Collaborators
Zhejiang University
Investigators
Principal Investigator: Jiren Yu The First Affiliated Hospital of Medical School of Zhejiang University
  More Information

No publications provided

Responsible Party: Jiren Yu, Zhejiang University
ClinicalTrials.gov Identifier: NCT01364376     History of Changes
Other Study ID Numbers: ZYYY-GC1105
Study First Received: May 19, 2011
Last Updated: July 29, 2014
Health Authority: China: Ethics Committee

Keywords provided by Zhejiang University:
Gastric Cancer

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Stomach Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Calcium, Dietary
Fluorouracil
Oxaliplatin
Leucovorin
Levoleucovorin
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 29, 2014