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

NCT ID: NCT01283217

Last Updated: 2013-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2016-03-31

Brief Summary

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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

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Conditions

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Gastric Adenocarcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DS(Docetaxel with S-1)

Docetaxel with S-1

Group Type EXPERIMENTAL

DS

Intervention Type DRUG

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

SP(S-1 with cisplatin)

S-1 with cisplatin

Group Type ACTIVE_COMPARATOR

SP

Intervention Type DRUG

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

Interventions

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DS

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

Intervention Type DRUG

SP

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

Intervention Type DRUG

Other Intervention Names

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Test group : DS * 8 cycles (S-1 70mg/m2/D, D1~14 plus Docetaxel 35 mg/m2 D1,8 q 3weeks) Control group : SP * 8 cycles (S-1 70mg/m2/D, D1~14 + Cisplatin 60mg2 D1, q 3 weeks)

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Severance Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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Sun-Young Rha, MD, Ph.D

Role: primary

82-2-2228-8050

Other Identifiers

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4-2009-0708

Identifier Type: -

Identifier Source: org_study_id

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