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The purpose of this study is to investigate the association between UGT1A1 polymorphisms and neutropenia and diarrhea in Korean patients with advanced colorectal or gastric cancer treated with FOLFIRI regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FOLFIRI | Experimental | Patients with colorectal cancer or gastric cancer will be treated with FOLFIRI(Irinotecan, 5FU, leucovorin) regimen upto 12 cycles. (Single arm study) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irinotecan, 5FU, leucovorin | Drug | FOLFIRI regimen every 2 weeks [irinotecan 150mg/m2 or 180mg/m2, leucovorin 20(200)mg/m2, 5FU 400 mg/m2 (bolus) or 2400 mg/m2 (46hour infusion)] |
| Measure | Description | Time Frame |
|---|---|---|
| Association between UGT1A1 polymorphism and grade 3/4 neutropenia after 1st cycle of FOLFIRI treatment | During the first cycle of treatment | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Association between UGT1A1 polymorphism and grade 3/4 neutropenia in all treatment duration | During all treatment period(during 12 cycle, each 2 weeks) | 24 weeks |
| Association between grade 3/4 diarrhea and UGT1A1 polymorphism |
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Inclusion Criteria:Subjects should meet all of the following criteria to participate in the trial.
Histologically confirmed colorectal or gastric cancer patients who are chemonaive or failed to 1st line chemotherapy
Subjects who are expected to receive toxicity test at least once after FOLFIRI treatment.
Aged 18 years or older.
ECOG performance status of ≤ 2.
Anticipated life expectancy of ≥ 3 months.
Clinically acceptable function of bone marrow, kidney and liver function as below.
Subjects whose written informed consent can be obtained prior to their participation in the trial.
Exclusion Criteria: Subjects who meet any of the following criteria should not be included in the trial.
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| Name | Affiliation | Role |
|---|---|---|
| YongSang Hong, Professor | Asan Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | Gangnam-gu | South Korea | |||
| Hwasun Hospital |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D013274 | Stomach Neoplasms |
| D009503 | Neutropenia |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000077146 | Irinotecan |
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D014498 | Uracil |
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|
During the first cycle of treatment
| 2 weeks |
| Progression-free survival | The time from registration to objective tumor progression or death | 6 months (average) |
| Jeonam |
| Hwasun-gun |
| South Korea |
| Korea Cancer Center Hospital | Seoul | Nowon-Gu | South Korea |
| Asan Medical Center | Seoul | Songpa-Gu | 05505 | South Korea |
| National Cancer Center | Goyang | South Korea |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D013272 | Stomach Diseases |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
| D011744 |
| Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |