The Efficacy of Oxaliplatin Plus S-1 for Treatment of Gastric Cancer
This study is currently recruiting participants.
Verified February 2012 by Chinese Academy of Medical Sciences
Sponsor:
Chinese Academy of Medical Sciences
Information provided by (Responsible Party):
Lin Yang, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01531452
First received: February 6, 2012
Last updated: February 10, 2012
Last verified: February 2012
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Purpose
The purpose of this study is to determine the efficacy and safety of oxaliplatin and s1 as first-line treatment of advanced gastric cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Stomach Neoplasms |
Drug: Oxaliplatin Drug: s1 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | a Phase II Study of Oxaliplatin Plus S-1 (SOX) as First-line Treatment for Patients With Advanced Gastric Cancer |
Resource links provided by NLM:
Further study details as provided by Chinese Academy of Medical Sciences:
Primary Outcome Measures:
- Progression Free Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]from date of treatment was administered until the date of first documented progression or death from any cause whichever first, assessed every 6 weeks
Secondary Outcome Measures:
- Response Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]From date of treatment was administered until the date of first documented response to treatment according to RECIST criteria,assessed every 2 cycles
- overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]From date of treatment was administered until the date of death from any cause,assessed every 3 months
- number of participants with adverse events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]assessed from treatment was administered until 1 months after withdrawing from study
| Estimated Enrollment: | 44 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: treatment
oxaliplatin+s1
|
Drug: Oxaliplatin
130mg/m2 d1,repeated q21d
Other Name: eloxatin
Drug: s1
80mg/m2/d, d1-14,repeated q21d
Other Name: TS-1
|
Detailed Description:
There was no evidence of standard chemotherapy for advanced gastric cancer (AGC) in China. Fluoropyrimidines and cisplatin have been widely used in a variety of combinations in the treatment of AGC. Capecitabine/cisplatin combination therapy showed an overall response rate (ORR) of 41- 55%, a median time to progression/progression free survival (TTP/PFS) of 5.6-6.3 months, and a median overall survival (OS) of 10.1-10.5 months. Though no studies have compared two oral fluoropyrimidines in combination with oxaliplatin, both S-1 and capecitabine appear to be comparable in terms of efficacy and safety. The investigators conducted a phase II trial of oxaliplatin combined with S-1 in the treatment of first-line AGC.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically proven in operable advanced gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction) or relapse gastric adenocarcinoma
- Measurable lesion and/or non-measurable lesion defined by RECIST
- ECOG performance status ≦ 1
- Hgb ≧ 8g/dL, WBC 4000-12000/mm3, platelets ≧ 100,000/mm3
- Creatine ≦ upper normal limit (UNL)
- Total bilirubin ≦ 1.5 X UNL
AST, ALT and ALP ≦ 2.5 x UNL
- Subjects must be able to take orally
- No prior chemotherapy
- Life expectancy estimated than 3 months
- Written informed consent
Exclusion Criteria:
Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant
- Known brain metastases
- History of hypersensitivity to fluoropyrimidines, oxaliplatin
- Active double cancer
- Treatment with any investigational product during the last 4 weeks prior to study entry
- Symptomatic peripheral neuropathy ≧ garde 2. by NCI-CTCAE ver.3.0
- Any previous chemotherapy or radiotherapy for AGC
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01531452
Contacts
| Contact: Wen Zhang, MD | 86-10-87788145 | |
| Contact: Lin Yang, MD | 86-10-87788145 | lyang69@sina.com.cn |
Locations
| China, Beijing | |
| cancer hospital & Institute,Chinese Academy of Medical Sciences | Recruiting |
| Beijing, Beijing, China, 100021 | |
| Contact: Wen Zhang, MD 86-10-87788145 | |
| Contact: Lin Yang, MD 86-10-87788145 lyang69@sina.com.cn | |
| Principal Investigator: Lin Yang, MD | |
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
| Principal Investigator: | Jinwan Wang, MD | cancer hospital&institute,Chinese Academy of Medical Sciences |
More Information
No publications provided
| Responsible Party: | Lin Yang, MD, Chinese Academy of Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT01531452 History of Changes |
| Other Study ID Numbers: | CH-GI-016 |
| Study First Received: | February 6, 2012 |
| Last Updated: | February 10, 2012 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Chinese Academy of Medical Sciences:
|
Stomach Neoplasms drug therapy oxaliplatin s1 |
Additional relevant MeSH terms:
|
Neoplasms Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases |
Gastrointestinal Diseases Stomach Diseases Oxaliplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013