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Sponsored by: |
National Cancer Center, Korea |
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Information provided by: | National Cancer Center, Korea |
ClinicalTrials.gov Identifier: | NCT00580359 |
This study is an open-label, single-center, and randomized phase II study designed to evaluate each efficacy and safety of S-1 and capecitabine in the elderly and/or poor performance status patients with recurrent or metastatic gastric cancer. The randomization will be stratified by age (70-85 years versus 65 years and < 70 years) and performance status, which is dependent on age group; in 70-85 years, ECOG performance status 0-1 versus 2 and in
65 years and <70 years, ECOG performance status 2 versus 3.
Condition | Intervention | Phase |
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Stomach Neoplasms |
Drug: S-1, capecitabine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Phase II Study of S-1 Versus Capecitabine as First-Line Chemotherapy in the Elderly and/or Poor Performance Status Patients With Recurrent or Metastatic Gastric Cancer |
Estimated Enrollment: | 96 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
S-1 40mg/m2 orally twice daily on days 1 (evening) - 15 (morning)
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Drug: S-1, capecitabine
S-1 40mg/m2 orally twice daily on days 1(evening) - 15 (morning)every 3 weeks, until disease progression, Capecitabine 1250mg/m2 orally twice daily on days 1 (evening) - 15 (morning)every 3 weeks, until disease progression
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B: Active Comparator
Capecitabine 1250mg/m2 orally twice daily on days 1 (evening) - 15 (morning)
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Drug: S-1, capecitabine
S-1 40mg/m2 orally twice daily on days 1(evening) - 15 (morning)every 3 weeks, until disease progression, Capecitabine 1250mg/m2 orally twice daily on days 1 (evening) - 15 (morning)every 3 weeks, until disease progression
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Ages Eligible for Study: | 60 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Measurable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) Measurable lesions:
Lesions that can be accurately measured in at least one dimension by any of the following:
Adequate major organ function including the following:
Hematopoietic function:
Hepatic function:
Renal function:
Exclusion Criteria:
Inadequate cardiovascular function:
Contact: Sook Ryun Park, M.D. | +82-31-920-1609 | sukryun73@ncc.re.kr |
Contact: So Yun Park, MS | +82-31-920-2309 | tomongmong@naver.com |
Korea, Republic of, Gyeonggi | |
National Cancer Center Korea | Recruiting |
Goyang, Gyeonggi, Korea, Republic of | |
Contact: Sook Ryun Park, M.D +82-31-920-1609 sukryun73@ncc.re.kr | |
Contact: So Yun Park, MS +82-31-920-2307 tomongmong@naver.com | |
Sub-Investigator: Noe Kyeong Kim, M.D | |
Sub-Investigator: Young Iee Park, M.D | |
Sub-Investigator: Byung-Ho Nam, M.D | |
Sub-Investigator: Hye Suk Han, M.D |
Principal Investigator: | Sook Ryun Park, M.D | National Cancer Center, Korea |
Responsible Party: | National Cancer Center, Korea ( Sook Ryun Park, M.D. ) |
Study ID Numbers: | NCCCTS-07-263 |
Study First Received: | December 21, 2007 |
Last Updated: | December 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00580359 History of Changes |
Health Authority: | Korea: Food and Drug Administration |
Stomach Neoplasms Secondary Combination chemotherapy S-1 Capecitabine |
Antimetabolites Capecitabine Stomach Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases |
Stomach Neoplasms Neoplasm Metastasis Gastrointestinal Neoplasms Stomach Cancer Recurrence |
Antimetabolites Capecitabine Digestive System Neoplasms Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Pharmacologic Actions |
Neoplasms Neoplasms by Site Digestive System Diseases Stomach Diseases Therapeutic Uses Stomach Neoplasms Gastrointestinal Neoplasms |