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| Name | Class |
|---|---|
| Ulsan University Hospital | OTHER |
| Hallym University Medical Center | OTHER |
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This study is designed to evaluate the efficacy of the intraperitoneal chemotherapy with early mitomycin administration and adding cisplatin to prolonged treatment with doxifluridine compared to mitomycin plus doxifluridine in resected advanced gastric cancer.
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 the intraperitoneal chemotherapy with early mitomycin administration and adding cisplatin to prolonged treatment with doxifluridine compared to mitomycin plus doxifluridine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mitomycin-C, Doxifluridine | Active Comparator | Mf: Mitomycin-C 20mg/m2 intravenously (3-6 weeks after surgery) Doxifluridine 460-600mg/m2/day per oral for 3 months (started 4 weeks after surgery) |
|
| Mitomycin-C, Doxifluridine, Cisplatin | Active Comparator | iceMFP: Cisplatin 100mg with 1L of normal saline intraperitoneally for 2 hours during surgery Mitomycin-C 15mg/m2 intravenously (1 day after surgery) Doxifluridine 460-600mg/m2/day per oral(started at 4 weeks after surgery and administered a total of 12 months) Cisplatin 60mg/m2 intravenously monthly for 6 months (started at 4 weeks after surgery) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin, mitomycin-C, doxifluridine | Drug | Mf: Mitomycin-C 20mg/m2 intravenously (3-6 weeks after surgery) Doxifluridine 460-600mg/m2/day per oral for 3 months (started 4 weeks after surgery) iceMFP: Cisplatin 100mg with 1L of normal saline intraperitoneally for 2 hours during surgery Mitomycin-C 15mg/m2 intravenously (1 day after surgery) Doxifluridine 460-600mg/m2/day per oral(started at 4 weeks after surgery and administered a total of 12 months) Cisplatin 60mg/m2 intravenously monthly for 6 months (started at 4 weeks after surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse-free Survival | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity Profile (According to NCI CTC Version 2.0) | Because safety profile in oncology study is evaluated for each toxicity, it is impossible to present the overall patient number. Instead, we presented the number of patients who declined study therapy due to adverse events or patient will. | up to 1 year |
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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 |
Although this study was originally designed to include 528 patients, a total 521 patients could be enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mitomycin and Short-term Fluoropyrimidine | Mitomycin-C 20mg/m2 intravenously (3-6 weeks after surgery) Doxifluridine 460-600mg/m2/day per oral for 3 months (started 4 weeks after surgery) |
| FG001 | iceMFP | Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mitomycin and Short-term Fluoropyrimidine | Mitomycin-C 20mg/m2 intravenously (3-6 weeks after surgery) Doxifluridine 460-600mg/m2/day per oral for 3 months (started 4 weeks after surgery) |
| BG001 | iceMFP |
| 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 | 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 and Short-term Fluoropyrimidine | Mitomycin-C 20mg/m2 intravenously (3-6 weeks after surgery) Doxifluridine 460-600mg/m2/day per oral for 3 months (started 4 weeks after surgery) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yoon-Koo Kang | Asan Medical Center, University of Ulsan College of Medicine | +82-2-3010-3230 | 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 |
|---|---|
| D002945 | Cisplatin |
| D016685 | Mitomycin |
| C025034 | doxifluridine |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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|
| Overall Survival |
| 3 years |
Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine
| 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 | Toxicity Profile (According to NCI CTC Version 2.0) | Because safety profile in oncology study is evaluated for each toxicity, it is impossible to present the overall patient number. Instead, we presented the number of patients who declined study therapy due to adverse events or patient will. | Posted | Number | participants | up to 1 year |
|
|
|
| Secondary | Overall Survival | Posted | Number | 95% Confidence Interval | percentage of participants | 3 years |
|
|
|
| 0 |
| 258 |
| 230 |
| 258 |
| EG001 | iceMFP | Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine | 0 | 263 | 251 | 263 |
| Anemia | Blood and lymphatic system disorders |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Elevated AST or ALT | Hepatobiliary disorders |
|
| Hyperbilirubinemia | Hepatobiliary disorders |
|
| Fatigue | General disorders |
|
| Anorexia | General disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Stomatitis | Gastrointestinal disorders |
|
| Constipation | Gastrointestinal disorders |
|
| Diarrhea | Gastrointestinal disorders |
|
| Alopecia | General disorders |
|
| Neuropathy | Nervous system disorders |
|
| Myalgia | Musculoskeletal and connective tissue disorders |
|
| Edema | Musculoskeletal and connective tissue disorders |
|
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| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D008937 |
| Mitomycins |
| D045563 | Indolequinones |
| D011809 | Quinones |
| D009930 | Organic Chemicals |
| D001389 | Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |