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

Yonsei University166 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

166

Conditions

Gastric Adenocarcinoma

Interventions

DSDRUG

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

SPDRUG

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

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Severance Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

3-year disease free survival(DFS)

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.

Time frame: 3 years

Data from ClinicalTrials.gov

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