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.
Verified May 2011 by Zhejiang University
Sponsor:
Zhejiang University
Information provided by:
Zhejiang University
ClinicalTrials.gov Identifier:
NCT01364376
First received: May 19, 2011
Last updated: June 13, 2011
Last verified: May 2011
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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:
Drug Information available for:
Fluorouracil
Calcium Gluconate
Leucovorin calcium
Oxaliplatin
Levoleucovorin
U.S. FDA Resources
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01364376
Contacts
| Contact: Jiren Yu | +86-571-87236147 | clinical_trials@163.com |
Locations
| China, Jiangsu | |
| Second Affiliated Hospital of Nanjing Medical University | Not yet recruiting |
| Nanjing, Jiangsu, China | |
| Contact: Baolin Wang aga670@163.com | |
| Sub-Investigator: Baolin Wang | |
| Suzhou Medical Hospital | Not yet recruiting |
| Suzhou, Jiangsu, China | |
| Contact: Hong yu 888yu@126.com | |
| Sub-Investigator: Hong yu | |
| 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 First Affiliated Hospital of Medical School of Zhejiang University | Recruiting |
| Hangzhou, Zhejiang, China | |
| Contact: Jiren yu clinical_trials@163.com | |
| Principal Investigator: Jiren Yu | |
| 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 | |
| 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: | June 13, 2011 |
| 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 June 18, 2013