UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000613 |
|---|---|
| Receipt number | R000000741 |
| Scientific Title | Phase II study of a combination of CPT-11, 5FU/l-LV and UFT/LV in patients with advanced/recurrent colorectal cancer |
| Date of disclosure of the study information | 2007/03/01 |
| Last modified on | 2009/12/04 17:37:15 |
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Basic information
Public title
Phase II study of a combination of CPT-11, 5FU/l-LV and UFT/LV in patients with advanced/recurrent colorectal cancer
Acronym
OGSG0605
Scientific Title
Phase II study of a combination of CPT-11, 5FU/l-LV and UFT/LV in patients with advanced/recurrent colorectal cancer
Scientific Title:Acronym
OGSG0605
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
Phase II study of a combination of CPT-11,5-FU/l-LV and UFT/LV in patients with advanced/recurrent colorectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
response rate
Key secondary outcomes
adverse events, overall survival,progression-free survival,time to treatment failure.
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
It takes 2 weeks for one course and that is to be repeated.
Dose schedule for one course
CPT-11 150mg/ m2/day Day 1
5-FU 500 mg/m2/day Day 1
l-LV 15 mg/m2/day Day 1
UFT 300 mg/m2/day Day 1-8 morning
LV 75 mg/day Day 1-8 morning
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) diagnosed as colon cancer
pathologically
2)with measurable lesions
3)without prior chemotherapy
4)without prior radiation therapy
5)20 years old <= => 75 years old
6)Performance status: 0 – 1 (ECOG)
7)Expected survival more than 12 weeks
8)Within labo. data level written,
subsequently
WBC >= 4,000/mm3 and <= 12,000/mm3
Neutrocyte >= 2,000/mm3
Platelet >= 100,000/mm3
sGOT, sGPT <upper limit of each
institute x 2.5
sBil <= 2.0mg/dl
creatinin <= upper limit of each
institute
Normal ECG
9)Informed Consents with written form
10) Patients who can take orally
Key exclusion criteria
1)interstitial pneumonitis or pulmonary
fibrosis
2)with cavity fluid to be treated
3)with present active double cancer or
D.B. diagnosed less than 5 years
before, excluding cured cancer in situ
or skin cancer
4)ileus
5)watery diarrhea
6)D.M. which needs insulin or
uncontrolled D.M.
7)With other diseases which influence
to the study (heart diseases, liver
dysfunction, renal failure)
8)brain metastasis with some symptoms
9)pregnant women or suspected women
10)receiving atazanavir sulfate
11)Receiving steroids treatment
12)With experience of drug anaphylaxis
shock
13)Doctor stop due to miscellaneous
factors
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | TAMURA TAKAO |
Organization
KOBE UNIVEISITY
Division name
Dpt.Digestive Diseases
Zip code
Address
7-5-1,Ksunokicho,Chuoku,Kobe 650-0017
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
OGSG
Division name
Office
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Osaka Gastrointestinal Cancer Chemotherapy Study Group (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 | 03 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2007 | Year | 01 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 02 | Month | 19 | Day |
Last modified on
| 2009 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000741
