Docetaxel and S1 (DS) Versus S1 and Cisplatin (SP) in Curatively Resected Stage IIIB/IV Gastric Cancer

Study Overview
=================
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).

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)

Conditions
-----------------
Gastric Adenocarcinoma

Intervention / Treatment
-----------------
* Drug: DS
* Drug: SP


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DS(Docetaxel with S-1)<br>Docetaxel with S-1 | Drug: DS<br>* Docetaxel with S-1. S-1: Orally, within 30 minutes after ingestion of food. Docetaxel and Cisplatin: IV infusion.<br>* Other names: (S-1 70mg/m2/D, D1 14 plus Docetaxel 35 mg/m2 D1,8 q 3weeks);|
| Active Comparator: SP(S-1 with cisplatin)<br>S-1 with cisplatin | Drug: SP<br>* S-1 with cisplatin. S-1 : Orally, within 30 minutes after ingestion of food. Docetaxel and Cisplatin: IV infusion.<br>* Other names: (S-1 70mg/m2/D, D1 14 + Cisplatin 60mg2 D1, q 3 weeks);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 years |