UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000766 |
|---|---|
| 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 |
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Basic information
Public 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)
Acronym
OGSG 0406
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)
Scientific Title:Acronym
OGSG 0406
Region
| Japan |
Condition
Condition
advanced/recurrent colorectal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Others
Basic objectives -Others
DLT,MTD,RD,Feasibility
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
DLT, MTD, RD
Key secondary outcomes
Feasibility
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
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
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
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
Key exclusion criteria
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
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fukunaga Mutsumi |
Organization
Sakai City Hospital
Division name
Dpt.Surgery
Zip code
Address
1-1-1,Minamiyasuicho,Sakai-ku,Sakai, 590-0064
TEL
072-221-1700
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Furukawa Hiroshi |
Organization
Sakai City Hospital
Division name
Director
Zip code
Address
1-1-1,Minamiyasuicho,Sakai-ku,Sakai, 590-0064
TEL
072-221-1700
Homepage URL
Sponsor or person
Institute
OGSG
Institute
Department
Personal name
Funding Source
Organization
NPO Osaka Chinical Study Supporting Organization
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 07 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2004 | Year | 09 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2005 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2005 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2006 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 07 | Month | 06 | Day |
Last modified on
| 2021 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000918
