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

Yonsei University

Status and phase

Unknown

Phase 3

Conditions

Gastric Adenocarcinoma

Treatments

Drug: SP

Drug: DS

Study type

Interventional

Funder types

Other

Identifiers

NCT01283217

4-2009-0708

Details and patient eligibility

About

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).

Enrollment

166 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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