Docetaxel and S1 (DS) Versus S1 and Cisplatin (SP) in Curatively Resected Stage IIIB/IV Gastric Cancer
NCT ID: NCT01283217
Last Updated: 2013-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
166 participants
INTERVENTIONAL
2010-03-31
2016-03-31
Brief Summary
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Based upon this background, the aim of this study is to detect a significant increase in 3 year DFS of disease for the test group (DS) relative to the Control group (SP).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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DS(Docetaxel with S-1)
Docetaxel with S-1
DS
Docetaxel with S-1. S-1: Orally, within 30 minutes after ingestion of food. Docetaxel and Cisplatin: IV infusion.
SP(S-1 with cisplatin)
S-1 with cisplatin
SP
S-1 with cisplatin. S-1 : Orally, within 30 minutes after ingestion of food. Docetaxel and Cisplatin: IV infusion.
Interventions
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DS
Docetaxel with S-1. S-1: Orally, within 30 minutes after ingestion of food. Docetaxel and Cisplatin: IV infusion.
SP
S-1 with cisplatin. S-1 : Orally, within 30 minutes after ingestion of food. Docetaxel and Cisplatin: IV infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ECOG performance status 0-1
* Curatively resected advanced gastric cancer patients of stage IIIb/IIIc
* D2 lymph node dissection with R0 surgery
* Signed informed consent
Exclusion Criteria
* Malabsorption syndrome or disease significantly affecting gastrointestinal function
* Patients with other uncontrolled systemic illness, e.g. infection, poorly controlled HTN
* History of other malignancy. Subjects who have been disease-free for 5 years or subjects with successfully treated in situ carcinoma are eligible.
* Subjects with preoperative/adjuvant other cancer treatment, such as chemotherapy, immunotherapy and radiotherapy
20 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Locations
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Severance Hospital
Seoul, , South Korea
Countries
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Facility Contacts
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Other Identifiers
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4-2009-0708
Identifier Type: -
Identifier Source: org_study_id
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