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

This study is currently recruiting participants.
Verified August 2011 by Yonsei University
Sponsor:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT01283217
First received: January 24, 2011
Last updated: August 15, 2011
Last verified: August 2011
History of Changes
  Purpose

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 Intervention Phase
Gastric Adenocarcinoma
 Drug: DS
Drug: SP
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • 3-year disease free survival(DFS) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 166
Study Start Date: March 2010
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01283217

Locations
Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Sun-Young Rha, MD, Ph.D     82-2-2228-8050     rha7655@yuhs.ac    
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Sun-Young Rha / Associate Professor, Severance Hospital, Department of Oncology
ClinicalTrials.gov Identifier: NCT01283217     History of Changes
Other Study ID Numbers: 4-2009-0708
Study First Received: January 24, 2011
Last Updated: August 15, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Adenocarcinoma
Adenocarcinoma, Mucinous
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Docetaxel
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013