Unique ID issued by UMIN | UMIN000000766 |
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Receipt number | R000000918 |
Scientific Title | A phase I study to evaluate the effect and recommended dose of 5-FU(rapid infusion and drip infusion)/l-LV therapy for advanced and/or recurrent colon cancer (OGSG 0406) |
Date of disclosure of the study information | 2007/07/13 |
Last modified on | 2021/11/15 23:03:58 |
A phase I study to evaluate the effect and recommended dose of 5-FU(rapid infusion and drip infusion)/l-LV therapy for advanced and/or recurrent colon cancer (OGSG 0406)
OGSG 0406
A phase I study to evaluate the effect and recommended dose of 5-FU(rapid infusion and drip infusion)/l-LV therapy for advanced and/or recurrent colon cancer (OGSG 0406)
OGSG 0406
Japan |
advanced/recurrent colorectal cancer
Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Malignancy
NO
A phase I clincal study is carried out to evaluate the dose limited toxicity, maximum tolerant dose, or recommended dose on 5-FU(rapid and continuous infusion) plus l-LV for advanced or recurrent colon cancer.
Others
DLT,MTD,RD,Feasibility
Phase I
DLT, MTD, RD
Feasibility
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Agents dose rout day
l-LV 200mg/m2 div(2 hours) day 1
5-FU 400mg/m2 iv(5 min) day 1
5-FU Xmg/m2 civ(46 hours) day 1
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1. histologically proven colon cancer
2. Age: 20-75 yo
3. Performance status: 0-1 (ECOG criteria)
4. without any prior chemotherapy or with longer than 4 weeks of no-therapy period after prior chemotherapy
5. with sufficient bone marrow, renal or hepatic function
Hemoglobin 8.0 g/dl <=
WBC: 4,000 /mm3 <= and =< 12,000/mm3
Neutrocyte: 2,000/mm3=<
Platelet: 100,000/mm3 =<
Total bilirubin: within normal range of each hospital
GOT, GPT: within 2 times of normal limit of each hospital
Creatinin: within normal range
CRP: 2mg/dl =>
BUN: <= 25mg/dl
alb: >=3g/dl
cardiac function: tolereble to the regimen of this study
6. without hepatitis virus infection (HBs Ag, HCV Ab)
7. expected survival period longer than 3 months
8. written informed consent
1.with severe bone marrow suppression
2.with a severe infection
3.with severe cardiac disease
4.with some other severe diseases
5.under a poor general condition
6.under diarrhea which continues more than three days
7.with double cancers which were treated within recent 5 years except carcinoma in situ.
8.with familial polyposis or hereditary disease
9.under pregnancy or nursing
10.with a history of allergic response to Levoholinate or fluorouracil
11.re-registration to this study
12.doctors' decision not to register
24
1st name | |
Middle name | |
Last name | Fukunaga Mutsumi |
Sakai City Hospital
Dpt.Surgery
1-1-1,Minamiyasuicho,Sakai-ku,Sakai, 590-0064
072-221-1700
1st name | |
Middle name | |
Last name | Furukawa Hiroshi |
Sakai City Hospital
Director
1-1-1,Minamiyasuicho,Sakai-ku,Sakai, 590-0064
072-221-1700
OGSG
NPO Osaka Chinical Study Supporting Organization
Self funding
NO
2007 | Year | 07 | Month | 13 | Day |
Unpublished
Completed
2004 | Year | 09 | Month | 09 | Day |
2004 | Year | 10 | Month | 01 | Day |
2005 | Year | 10 | Month | 01 | Day |
2005 | Year | 11 | Month | 01 | Day |
2006 | Year | 03 | Month | 01 | Day |
2007 | Year | 03 | Month | 01 | Day |
2007 | Year | 07 | Month | 06 | Day |
2021 | Year | 11 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000918
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