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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S-1 | Active Comparator |
| |
| Capecitabine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-1 | Drug |
| ||
| Capecitabine |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | 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. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Adverse Events | Per National Cancer Institute Common Toxicity Criteria Version 2.0, up to 2 years | Up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yoon-Koo Kang, M.D., Ph.D. | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center | Goyang-si | Gyeonggi-do | South Korea | |||
| Hallym University Sacred Heart Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | S-1 for 2 Week on/1 Week Off | S-1 was given orally two times daily for 28 days, followed by 14 days' rest. Three dosage levels of S-1 were defined according to body surface area (BSA) as follows: BSA less than 1.25 m2, 40mg two times daily; BSA, 1.25 to 1.5 m2, 50 mg, two times daily; and BSA more than 1.5 m2, 60 mg two times daily. |
| FG001 | Capecitabine 2 Weeks on/1 Week Off | Capecitabine 2500 mg square meter was administered orally in two divided doses daily on days 1-14 of a 21-day cycle. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | S-1 for 2 Weeks on/1 Week Off | S-1 was given orally two times daily for 28 days, followed by 14 days' rest. Three dosage levels of S-1 were defined according to body surface area (BSA) as follows: BSA less than 1.25 m2, 40mg two times daily; BSA, 1.25 to 1.5 m2, 50 mg, two times daily; and BSA more than 1.5 m2, 60 mg two times daily. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Response Rate | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 2 years |
|
Up to 2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | S-1 for 2 Week on/1 Week Off | S-1 was given orally two times daily for 28 days, followed by 14 days' rest. Three dosage levels of S-1 were defined according to body surface area (BSA) as follows: BSA less than 1.25 m2, 40mg two times daily; BSA, 1.25 to 1.5 m2, 50 mg, two times daily; and BSA more than 1.5 m2, 60 mg two times daily. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | NCI_CTCAE ver2.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yoon-Koo Kang | Asan Medical Center | +82-2-3010-3210 | ykkang@amc.seoul.kr |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C079198 | S 1 (combination) |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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|
| Pyeongchon |
| Gyeonggido |
| South Korea |
| Kyung Pook National University Hospital | Daegu | South Korea |
| Yeungnam University Medical Center | Daegu | South Korea |
| Gacheon Medical School Gil Medical Center | Incheon | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Korea Cancer Center Hospital | Seoul | South Korea |
| Seoul Samsung Medical Center | Seoul | South Korea |
| Ulsan University Hospital | Ulsan | South Korea |
| BG001 |
| Capecitabine 2 Weeks on/1 Week Off |
Capecitabine 2500 mg square meter was administered orally in two divided doses daily on days 1-14 of a 21-day cycle. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Capecitabine 2 Weeks on/1 Week Off | Capecitabine 2500 mg square meter was administered orally in two divided doses daily on days 1-14 of a 21-day cycle. |
|
|
| Secondary | Number of Patients With Adverse Events | Per National Cancer Institute Common Toxicity Criteria Version 2.0, up to 2 years | Posted | Number | participants | Up to 2 years |
|
|
|
| 0 |
| 42 |
| 42 |
| 42 |
| EG001 | Capecitabine 2 Weeks on/1 Week Off | Capecitabine 2500 mg square meter was administered orally in two divided doses daily on days 1-14 of a 21-day cycle. | 0 | 44 | 44 | 44 |
| Leukopenia | Blood and lymphatic system disorders | NCI_CTCAE ver2.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | NCI_CTCAE ver2.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | NCI_CTCAE ver2.0 | Systematic Assessment |
|
| Asthenia | General disorders | NCI_CTCAE ver2.0 | Systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | NCI_CTCAE ver2.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | NCI_CTCAE ver2.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | NCI_CTCAE ver2.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | NCI_CTCAE ver2.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | NCI_CTCAE ver2.0 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | NCI_CTCAE ver2.0 | Systematic Assessment |
|
| Hand-foot syndrome | Skin and subcutaneous tissue disorders | NCI_CTCAE ver2.0 | Systematic Assessment |
|
| Hyperbilirubinemia | Hepatobiliary disorders | NCI_CTCAE ver2.0 | Systematic Assessment |
|
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| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |