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

NCT01283217 | Unknown Phase 3 DMC

• 1 other identifier: 4-2009-0708
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

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).

Conditions

Gastric Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  3 years

Study Arms (2)

DS(Docetaxel with S-1)

EXPERIMENTAL

Docetaxel with S-1

Drug: DS

SP(S-1 with cisplatin)

ACTIVE COMPARATOR

S-1 with cisplatin

Drug: SP

Interventions

DS DRUG

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

Also known as: Test group : DS * 8 cycles, (S-1 70mg/m2/D, D1~14 plus Docetaxel 35 mg/m2 D1,8 q 3weeks)

DS(Docetaxel with S-1)

SP DRUG

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

Also known as: Control group : SP * 8 cycles, (S-1 70mg/m2/D, D1~14 + Cisplatin 60mg2 D1, q 3 weeks)

SP(S-1 with cisplatin)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

RECRUITING

MeSH Terms

Interventions

S 1 (combination); Docetaxel; Cisplatin

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2011
• First Posted: January 25, 2011
• Study Start: March 1, 2010
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: June 4, 2013

Record last verified: 2013-06

Locations

KR (1)