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Capecitabine Versus S-1 in Elderly Advanced Gastric Cancer (AGC): Randomized Trial

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: January 19, 2006
Last Update Posted: February 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yoon-Koo Kang, Asan Medical Center
A significant proportion of advanced gastric cancer (AGC) occurs in individuals 65 years of age and older. In addition, patient delay in seeking care for symptoms results in diagnosis at a more advanced stage than that seen in younger individuals. However, clinical trials on gastric cancer rarely have been available to the elderly. Recently oral 5-FU pro-drugs, which have been reported to have clinically significant response rates and survival with mild or negligible toxicities, have been widely used for the patients with AGC. However, few studies have been conducted in elderly patients.

Condition Intervention Phase
Gastric Cancer Drug: S-1 Drug: Capecitabine Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Multicenter Phase II Trial of Capecitabine Versus S-1 as First-line Treatment in Elderly Patients With Advanced or Recurrent Unresectable Gastric Cancer

Resource links provided by NLM:

Further study details as provided by Yoon-Koo Kang, Asan Medical Center:

Primary Outcome Measures:
  • Response Rate [ Time Frame: Up to 2 years ]

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Progressive disease (PD), >20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), Insufficient change to qualify for PR or PD

    Response rate is defined as the proportion of patients who showed OR.

Secondary Outcome Measures:
  • Number of Patients With Adverse Events [ Time Frame: Up to 2 years ]
    Per National Cancer Institute Common Toxicity Criteria Version 2.0, up to 2 years

Enrollment: 96
Study Start Date: November 2004
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: S-1 Drug: S-1
Active Comparator: Capecitabine Drug: Capecitabine


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Pathologically proven gastric or gastroesophageal junction adenocarcinoma
  • Metastatic or recurrent unresectable disease
  • Measurable lesions (according to Response Evaluation Criteria in Solid Tumors [RECIST])
  • Age: 65-85 years old
  • Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2
  • Adequate bone marrow function: absolute neutrophile counts(ANC) ≥ 1,500/ul, platelet count ≥ 100,000/ul, hemoglobin ≥ 9 g/dl)
  • Adequate renal function (serum creatinine≤ 1.5)
  • Adequate liver function (serum bilirubin ≤ 2 x upper limits of normal [UNL], aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 x UNL)
  • No prior chemotherapy (but adjuvant chemotherapy completed at least 1 year prior to study treatment is allowed with the exception of capecitabine or S-1) Written informed consent was signed by the patient

Exclusion Criteria:

  • Previous palliative chemotherapy
  • Known allergy to study drugs
  • CNS metastasis
  • Significant medical comorbidities
  • Active ongoing infection which antibiotic treatment is needed.
  • Previous ( within 5 years) history of other malignancy except cured non-malignant skin cancer and uterine cervical cancer in situ.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00278863

Korea, Republic of
National Cancer Center
Goyang, Gyeonggi-do, Korea, Republic of
Hallym University Sacred Heart Hospital
Pyeongchon, Gyeonggido, Korea, Republic of
Kyung Pook National University Hospital
Daegu, Korea, Republic of
Yeungnam University Medical Center
Daegu, Korea, Republic of
Gacheon Medical School Gil Medical Center
Incheon, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Korea Cancer Center Hospital
Seoul, Korea, Republic of
Seoul Samsung Medical Center
Seoul, Korea, Republic of
Ulsan University Hospital
Ulsan, Korea, Republic of
Sponsors and Collaborators
Asan Medical Center
Principal Investigator: Yoon-Koo Kang, M.D., Ph.D. Asan Medical Center
  More Information

Responsible Party: Yoon-Koo Kang, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00278863     History of Changes
Other Study ID Numbers: AMC-ONCGI-0415
First Submitted: January 17, 2006
First Posted: January 19, 2006
Results First Submitted: January 13, 2014
Results First Posted: February 25, 2014
Last Update Posted: February 25, 2014
Last Verified: January 2014

Keywords provided by Yoon-Koo Kang, Asan Medical Center:
Stomach cancer
Palliative chemotherapy

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents