Back to resultsDocetaxel and S1 (DS) Versus S1 and Cisplatin (SP) in Curatively Resected Stage IIIB/IV Gastric Cancer
Primary Purpose
Gastric Adenocarcinoma
Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DS
SP
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Adenocarcinoma
Eligibility Criteria
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
Sites / Locations
- Severance HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DS(Docetaxel with S-1)
SP(S-1 with cisplatin)
Arm Description
Docetaxel with S-1
S-1 with cisplatin
Outcomes
Primary Outcome Measures
3-year disease free survival(DFS)
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01283217
Brief Title
Docetaxel and S1 (DS) Versus S1 and Cisplatin (SP) in Curatively Resected Stage IIIB/IV Gastric Cancer
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
March 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Adenocarcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
166 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DS(Docetaxel with S-1)
Arm Type
Experimental
Arm Description
Docetaxel with S-1
Arm Title
SP(S-1 with cisplatin)
Arm Type
Active Comparator
Arm Description
S-1 with cisplatin
Intervention Type
Drug
Intervention Name(s)
DS
Other Intervention Name(s)
Test group : DS * 8 cycles, (S-1 70mg/m2/D, D1~14 plus Docetaxel 35 mg/m2 D1,8 q 3weeks)
Intervention Description
Docetaxel with S-1. S-1: Orally, within 30 minutes after ingestion of food. Docetaxel and Cisplatin: IV infusion.
Intervention Type
Drug
Intervention Name(s)
SP
Other Intervention Name(s)
Control group : SP * 8 cycles, (S-1 70mg/m2/D, D1~14 + Cisplatin 60mg2 D1, q 3 weeks)
Intervention Description
S-1 with cisplatin. S-1 : Orally, within 30 minutes after ingestion of food. Docetaxel and Cisplatin: IV infusion.
Primary Outcome Measure Information:
Title
3-year disease free survival(DFS)
Description
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.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sun-Young Rha, MD, Ph.D
Phone
82-2-2228-8050
Email
rha7655@yuhs.ac
12. IPD Sharing Statement
Learn more about this trial
Docetaxel and S1 (DS) Versus S1 and Cisplatin (SP) in Curatively Resected Stage IIIB/IV Gastric Cancer
We'll reach out to this number within 24 hrs