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

Sponsor

Yonsei University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01283217

Collaborator

(none)

166

Enrollment

Location

Arms

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Gastric Adenocarcinoma	Drug: DS Drug: SP	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

166 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Study Start Date :

Mar 1, 2010

Anticipated Primary Completion Date :

Mar 1, 2016

Anticipated Study Completion Date :

Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DS(Docetaxel with S-1) Docetaxel with S-1	Drug: DS Docetaxel with S-1. S-1: Orally, within 30 minutes after ingestion of food. Docetaxel and Cisplatin: IV infusion. Other Names: Test group : DS * 8 cycles (S-1 70mg/m2/D, D1~14 plus Docetaxel 35 mg/m2 D1,8 q 3weeks)
Active Comparator: SP(S-1 with cisplatin) S-1 with cisplatin	Drug: SP S-1 with cisplatin. S-1 : Orally, within 30 minutes after ingestion of food. Docetaxel and Cisplatin: IV infusion. Other Names: Control group : SP * 8 cycles (S-1 70mg/m2/D, D1~14 + Cisplatin 60mg2 D1, q 3 weeks)

Arm

Intervention/Treatment

Experimental: DS(Docetaxel with S-1)

Docetaxel with S-1

Drug: DS

Docetaxel with S-1. S-1: Orally, within 30 minutes after ingestion of food. Docetaxel and Cisplatin: IV infusion.

Other Names:

Test group : DS * 8 cycles

(S-1 70mg/m2/D, D1~14 plus Docetaxel 35 mg/m2 D1,8 q 3weeks)

Active Comparator: SP(S-1 with cisplatin)

S-1 with cisplatin

Drug: SP

S-1 with cisplatin. S-1 : Orally, within 30 minutes after ingestion of food. Docetaxel and Cisplatin: IV infusion.

Other Names:

Control group : SP * 8 cycles

(S-1 70mg/m2/D, D1~14 + Cisplatin 60mg2 D1, q 3 weeks)

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Severance Hospital	Seoul		Korea, Republic of	120-752

Sponsors and Collaborators

Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT01283217

Other Study ID Numbers:

4-2009-0708

First Posted:

Jan 25, 2011

Last Update Posted:

Jun 4, 2013

Last Verified:

Jun 1, 2013

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 4, 2013