UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000727 |
|---|---|
| Receipt number | R000000872 |
| Scientific Title | Phase II study of a combination of modified CPT-11 and 5-FU/l-LV (mJIFL) in patients with meatastatic colorectal cancer |
| Date of disclosure of the study information | 2007/06/08 |
| Last modified on | 2009/12/04 17:40:39 |
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Basic information
Public title
Phase II study of a combination of modified CPT-11 and 5-FU/l-LV (mJIFL) in patients with meatastatic colorectal cancer
Acronym
OGSG 0601
Scientific Title
Phase II study of a combination of modified CPT-11 and 5-FU/l-LV (mJIFL) in patients with meatastatic colorectal cancer
Scientific Title:Acronym
OGSG 0601
Region
| Japan |
Condition
Condition
Meatastatic colorectal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A Phase II study of modified CPT-11 and 5-FU/l-LV (mJIFL) for the patients with meatastatic colorectal cancer is carried out to evaluate the response and to know the feasibility.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Response Rate
Key secondary outcomes
Time To Progression(TTP), Time To Treatment Failure (TTF), Survival Time, Relative Dose Intensity
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
On Day 1, 8, 15,
CPT-11 100 mg/m2
l-LV 250 mg/m2 administered simultaneously
5-FU 500 mg/m2 administered subsequently
** It takes 28 days for the one course.
** More than two courses are required.
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) advanced or recurrent colon cancer with metastatic lesions
2) colon cancer proven by cytologic and/or histologic examination
3) with measurable lesions which are larger than 2 cm by CT sliced 10 mm
or larger than 1cm by CT sliced 5 mm.
4) without any prior chemotherapy, or with prior CPT-11 therapy after 4
Weeks of last administration
5) without radiation therapy
6) age: 20 <= and => 75 years old
7) performance status: 0-1(ECOG classification)
8) Expected survival period is longer than 13 weeks.
9) with sufficient function on the important organs
WBC 3,000<= and =< 12,000 mm3/dl
Neutrocyte 1,500mm3 <=
Hemoglobin 8.0 g.dl <=
Platelet 100,000/mm3 <=
Total bilirubin within 1.5 times of normal range of each institute
AST, ALT within 2.5 times of normal range in each institute
Serum creatinin within normal range of each institute
ECG normal range
10) written informed consents
Key exclusion criteria
1. with interstitial pneumonitis or pulmonary fibrosis
2. cavity fluid which should be taken out
3. with double cancer and/or multiple cancer which excludes carcinoma in situ
4. with infectious disease, intestinal paralysis, or intestinal obstraction
5. under the condition of diarrhea (watery diarrhea)
6. under insulin therapy or uncontrolled DM
7. with ulcer on digestive organs
8. with ischemic cardiac disease
9. with psychological disorder which disturb the entry to the study
10. under HBs-Antigen(+), HCV antibody(+), or HIV antibody(+)
11. under continuous steroids therapy
12. with other severe diseases(cardiac failure, liver dysfunction, or renal
dysfunction)
13. brain metastasis with some symptoms
14. pregnant and/or nursing women
15. with allergic history against medicines
16. doctors' stop not to register to the study
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mishima Hideyuki |
Organization
National Hospital Organization Osaka National Hospital
Division name
Dpt.Surgery
Zip code
Address
2-1-14,Houenzaka,Chuou-ku,Osaka,540-0006
TEL
06-6942-1331
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 | 06 | Month | 08 | 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
| 2006 | Year | 03 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 05 | Month | 31 | 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=R000000872
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