- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01283217
Docetaxel and S1 (DS) Versus S1 and Cisplatin (SP) in Curatively Resected Stage IIIB/IV Gastric Cancer
A Randomized, Multicenter, Open-label, Phase III Trial of Docetaxel and S1 (DS) Versus S1 and Cisplatin (SP) in Curatively Resected (D2) Gastric Cancer of Stage IIIB/IV (M0)
Docetaxel was the first drug that showed survival benefits when added to the CF regimen, but it was very toxic. Docetaxel is also has a synergistic anti-cancer effect with S-1, in phase I/II studies. The use of a docetaxel plus S-1 combination as first-line chemotherapy for advanced gastric cancer achieved response rates of 46~56% and a median survival time of 14.0~14.3 months.
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).
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Seoul, Korea, Republic of, 120-752
- Recruiting
- Severance Hospital
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Contact:
- Sun-Young Rha, MD, Ph.D
- Phone Number: 82-2-2228-8050
- Email: rha7655@yuhs.ac
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically proven, Stage IIIb/ IIIc curatively resected gastric carcinoma
- 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:
- Subjects with documented distant metastasis.
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DS(Docetaxel with S-1)
Docetaxel with S-1
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Docetaxel with S-1.
S-1: Orally, within 30 minutes after ingestion of food.
Docetaxel and Cisplatin: IV infusion.
Other Names:
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Active Comparator: SP(S-1 with cisplatin)
S-1 with cisplatin
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S-1 with cisplatin.
S-1 : Orally, within 30 minutes after ingestion of food.
Docetaxel and Cisplatin: IV infusion.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
3-year disease free survival(DFS)
Time Frame: 3 years
|
Tumor assessments with chest X-rays and CT or MRI scan will be done at 6 months after randomization (after the end of the treatment period), then every 3 months for the first 2 years after randomization and then every 6 months for coming 3 years then one year basis until completion of the study.
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3 years
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Stomach Neoplasms
- Adenocarcinoma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Docetaxel
- Cisplatin
Other Study ID Numbers
- 4-2009-0708
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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