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

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.
 
ClinicalTrials.gov Identifier: NCT00278863
Recruitment Status : Completed
First Posted : January 19, 2006
Results First Posted : February 25, 2014
Last Update Posted : February 25, 2014
Sponsor:
Information provided by (Responsible Party):
Yoon-Koo Kang, Asan Medical Center

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Gastric Cancer Drug: S-1 Drug: Capecitabine Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
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
Study Start Date : November 2004
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: S-1 Drug: S-1
Active Comparator: Capecitabine Drug: Capecitabine


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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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


Locations
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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
Investigators
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Principal Investigator: Yoon-Koo Kang, M.D., Ph.D. Asan Medical Center
More Information
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Responsible Party: Yoon-Koo Kang, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00278863    
Other Study ID Numbers: AMC-ONCGI-0415
First Posted: January 19, 2006    Key Record Dates
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
Capecitabine
S-1
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
 Stomach Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents