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Trial Title:
Docetaxel and S1 (DS) Versus S1 and Cisplatin (SP) in Curatively Resected Stage IIIB/IV Gastric Cancer
NCT ID:
NCT01283217
Condition:
Gastric Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Cisplatin
Docetaxel
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Factorial Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
DS
Description:
Docetaxel with S-1. S-1: Orally, within 30 minutes after ingestion of food. Docetaxel and
Cisplatin: IV infusion.
Arm group label:
DS(Docetaxel with S-1)
Other name:
Test group : DS * 8 cycles
Other name:
(S-1 70mg/m2/D, D1~14 plus Docetaxel 35 mg/m2 D1,8 q 3weeks)
Intervention type:
Drug
Intervention name:
SP
Description:
S-1 with cisplatin. S-1 : Orally, within 30 minutes after ingestion of food. Docetaxel
and Cisplatin: IV infusion.
Arm group label:
SP(S-1 with cisplatin)
Other name:
Control group : SP * 8 cycles
Other name:
(S-1 70mg/m2/D, D1~14 + Cisplatin 60mg2 D1, q 3 weeks)
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).
Criteria for 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
Gender:
All
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Severance Hospital
Address:
City:
Seoul
Zip:
120-752
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Sun-Young Rha, MD, Ph.D
Phone:
82-2-2228-8050
Email:
rha7655@yuhs.ac
Start date:
March 2010
Completion date:
March 2016
Lead sponsor:
Agency:
Yonsei University
Agency class:
Other
Source:
Yonsei University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01283217
