Docetaxel and S1 (DS) Versus S1 and Cisplatin (SP) in Curatively Resected Stage IIIB/IV Gastric Cancer
Conditions
Gastric Adenocarcinoma
Conditions: official terms
Adenocarcinoma
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: DS Type: Drug
Name: SP Type: Drug
Overall Status
Recruiting
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
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 20 Years
Gender: Both
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
Location
Severance Hospital
Seoul, Korea, Republic of
Status: Recruiting
Contact: Sun-Young Rha, MD, Ph.D - 82-2-2228-8050 - rha7655@yuhs.ac
Start Date
March 2010
Completion Date
March 2016
Sponsors
Yonsei University
Source
Yonsei University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page