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

Phase 3

• Conditions: Gastric Adenocarcinoma
• Interventions: Drug: DS; Drug: SP

• Registration Number: NCT01283217
• Lead Sponsor: Yonsei University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2011-01-24
• Study First Submitted QC: 2011-01-24
• Study First Posted: 2011-01-25
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-01
• Last Update Posted: 2013-06-04
• Primary Completion: 2016-03
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 166

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
DS(Docetaxel with S-1)	DS	Docetaxel with S-1
SP(S-1 with cisplatin)	SP	S-1 with cisplatin

Primary Outcome Measures

Name	Time	Method
3-year disease free survival(DFS)	3 years	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.

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of