The Efficacy of Oxaliplatin Plus S-1 for Treatment of Gastric Cancer
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ClinicalTrials.gov Identifier: NCT01531452 |
Recruitment Status :
Completed
First Posted : February 13, 2012
Last Update Posted : December 4, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Stomach Neoplasms | Drug: Oxaliplatin Drug: s1 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 43 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | June 2011 |
Actual Primary Completion Date : | November 2012 |
Actual Study Completion Date : | June 2013 |

Arm | Intervention/treatment |
---|---|
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 |
- Progression Free Survival [ Time Frame: 2 years ]from date of treatment was administered until the date of first documented progression or death from any cause whichever first, assessed every 6 weeks
- Response Rate [ Time Frame: 2 years ]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 ]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 ]assessed from treatment was administered until 1 months after withdrawing from study

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01531452
China, Beijing | |
cancer hospital & Institute,Chinese Academy of Medical Sciences | |
Beijing, Beijing, China, 100021 |
Principal Investigator: | Jinwan Wang, MD | cancer hospital&institute,Chinese Academy of Medical Sciences |
Responsible Party: | Lin Yang, MD, Chinese Academy of Medical Sciences |
ClinicalTrials.gov Identifier: | NCT01531452 |
Other Study ID Numbers: |
CH-GI-016 |
First Posted: | February 13, 2012 Key Record Dates |
Last Update Posted: | December 4, 2014 |
Last Verified: | December 2014 |
Stomach Neoplasms drug therapy oxaliplatin s1 |
Stomach Neoplasms Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Oxaliplatin Antineoplastic Agents |