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| Name | Class |
|---|---|
| Ulsan University Hospital | OTHER |
| Hallym University Medical Center | OTHER |
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This is a phase III randomized study designed to evaluate the efficacy of mitomycin, doxifluridine, and cisplatin compared to mitomycin and doxifluridine.
Stomach cancer is the most common cancer in Korea and one of the major health problems worldwide. The most effective treatment for gastric cancer is curative surgical resection of primary tumor. However, a substantial number of patients eventually die of recurrences after curative resection. A number of randomized trials investigating the role of adjuvant chemotherapy have been conducted. However, the efficacy of adjuvant chemotherapy is still controversial and varied between Western and Asian trials. Meta-analysis of Western trials didn't demonstrate the benefit of adjuvant chemotherapy after curative resection. Conversely, some Asian studies have demonstrated the efficacy of adjuvant chemotherapy after curative resection. In a previous study, mitomycin plus tegafur prolonged the survival in resected gastric cancer compared to no treatment.
This study is designed to evaluate the efficacy of mitomycin, cisplatin and prolonged treatment with doxifluridine compared to mitomycin plus doxifluridine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mitomycin and doxifluridine | Active Comparator | Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84) |
|
| Mitomycin, doxifluridine and cisplatin | Experimental | Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitomycin, doxifluridine and cisplatin | Drug | Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168) |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse-free Survival Rate | Relapse-free survival at 3 years was defined as the proportion of patients who did not show an evidence of disease recurrence after 3 years of surgery. Relapse was defined as any new tumor lesion. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival Rate | Overall survival rate at 3 years was defined as the proportion of patients who were alive at 3 years after surgery. | 3 years |
| Number of Patients With Adverse Events | Per National Cancer Institute Common Toxicity Criteria version 2.0, up to 3 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 |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | 138-736 | South Korea |
All enrolled patients received study treatments
AMC0201 was an open-label, prospective randomised phase 3 clinical trial conducted at three centres (Asan medical center, Hallym University medical center, and Ulsan university hospital) in Korea. Patients were enrolled between February 2002 and August 2006
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| ID | Title | Description |
|---|---|---|
| FG000 | Mitomycin and Doxifluridine | Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84) |
| FG001 | Mitomycin, Doxifluridine and Cisplatin | Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled patients were included in the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Mitomycin and Doxifluridine | Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168) |
| BG001 | Mitomycin, Doxifluridine and Cisplatin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Relapse-free Survival Rate | Relapse-free survival at 3 years was defined as the proportion of patients who did not show an evidence of disease recurrence after 3 years of surgery. Relapse was defined as any new tumor lesion. | Intention-to treat population | Posted | Number | 95% Confidence Interval | percentage of participants | 3 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 | Mitomycin Plus Short-term Fluoropyrimidine | Control arm |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | NCI_CTC version 2.0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | NCI_CTC version 2.0 | 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 |
|---|---|
| D016685 | Mitomycin |
| C025034 | doxifluridine |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D008937 | Mitomycins |
| D045563 | Indolequinones |
| D011809 | Quinones |
| D009930 | Organic Chemicals |
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| Mitomycin and doxifluridine | Drug | Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84) |
|
| Up to 3 years |
| Lost to Follow-up |
|
| Physician Decision |
|
Experimental armMitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Overall Survival Rate | Overall survival rate at 3 years was defined as the proportion of patients who were alive at 3 years after surgery. | Posted | Number | 95% Confidence Interval | percentage of participants | 3 years |
|
|
|
| Secondary | Number of Patients With Adverse Events | Per National Cancer Institute Common Toxicity Criteria version 2.0, up to 3 years | Posted | Number | participants | Up to 3 years |
|
|
|
| 3 |
| 422 |
| 393 |
| 422 |
| EG001 | Mitomycin Plus Long-term Fluoropyrimidine and Monthly Cisplati | Experimental arm | 5 | 425 | 413 | 425 |
| Vomiting | Gastrointestinal disorders | NCI_CTC version 2.0 |
|
| Anemia | Blood and lymphatic system disorders | NCI_CTC version 2.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | NCI_CTC version 2.0 | Systematic Assessment |
|
| Hyperbilirubinemia | Hepatobiliary disorders | NCI_CTC version 2.0 | Systematic Assessment |
|
| Fatigue | General disorders | NCI_CTC version 2.0 | Systematic Assessment |
|
| Anorexia | General disorders | NCI_CTC version 2.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | NCI_CTC version 2.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | NCI_CTC version 2.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | NCI_CTC version 2.0 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | NCI_CTC version 2.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | NCI_CTC version 2.0 | Systematic Assessment |
|
| Neuropathy | Nervous system disorders | NCI_CTC version 2.0 | Systematic Assessment |
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| Hand-foot syndrome | Skin and subcutaneous tissue disorders | NCI_CTC version 2.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | NCI_CTC version 2.0 | Systematic Assessment |
|
| Edema | Musculoskeletal and connective tissue disorders | NCI_CTC version 2.0 | Systematic Assessment |
|
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| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D001389 |
| Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| Thrombocytopenia |
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| Fatigue |
|
| Diarrhea |
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| Nausea |
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| Vomiting |
|