UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000740 |
|---|---|
| Receipt number | R000000889 |
| Scientific Title | Pre-operative chemotherapy with FOLFOX4 in potentially resectable liver metastases from colorectal origin. Pilot phase II study |
| Date of disclosure of the study information | 2007/06/22 |
| Last modified on | 2009/12/04 17:36:44 |
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Basic information
Public title
Pre-operative chemotherapy with FOLFOX4 in potentially resectable liver metastases from colorectal origin. Pilot phase II study
Acronym
OGSG0506
Scientific Title
Pre-operative chemotherapy with FOLFOX4 in potentially resectable liver metastases from colorectal origin. Pilot phase II study
Scientific Title:Acronym
OGSG0506
Region
| Japan |
Condition
Condition
patients with liver metastasis from colon cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility and adverse events on a phase II study of pre-operative OLFOX4 for patients with potentially resectable liver metastases from colorectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Resection rate on the liver
Key secondary outcomes
Rate of completion on preoperative chemotherapy
Adverse events
Response rate
Time to progression
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
Registration – (2 weeks) - FOLFOX4 4 courses – (4-7 weeks) - Surgical operation
FOLFOX4
Day 1
1. L-OHP 85mg/m2 is diluted by 250 ml of 5%glucose (A)
2. l-LV 100mg/m2 is diluted by 250 ml of 5% glucose (B)
3. A and B is mixed by connecting Y tube and infused by 2 hours.
4. 5-FU 400mg/m2 is infused by 15 minutes.
5. 5-Fu 600 mg/m2 is infused by 2 hours.
Day 2
1. l-LV 100mg/m2 is infused by 2 hours.
2. 5-FU 400mg/m2 is infused by 15 minutes.
3. 5-Fu 600 mg/m2 is infused by 2 hours.
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) colorectal cancer, cytologically and/or histologically
(2) without prior L-OHP therapy or without any other prior chemotherapy within 8 weeks
(3) with measurable lesions in the liver
(4) resectable lesions in the liver
(5) Expected function is enough on the remnant liver
(6) Age: 20 years old =< and =>75 years old
(7) Performance Status: 0-1 in ECOG criteria
(8) Longer than 12 weeks of expected survival
(9) sufficient function in the important organs
WBC 4,000<= and =< 12,000 mm3/dl
Neutrocyte >= 2,000/mm3
Platelet 100,000/mm3 <=
Hemoglobin >= 8.0 g/dl
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
%PT or HPT >= 70%
ECG normal range
10) written informed consents
Key exclusion criteria
1. cavity fluid which should be taken out
2. with double cancer and/or multiple cancer which excludes carcinoma in situ
3. with peripheral nerve disorder
4. with infectious disease
5. under the condition of diarrhea (watery diarrhea)
6. with psychological disorder which disturb the entry to the study
7. under continuous steroids therapy
8. with other severe diseases (pulmonary fibrosis, cardiac failure, liver dysfunction, renal dysfunction, intestinal paralysis/obstruction or uncontrolled DM)
9. pregnant and/or nursing women
10. with allergic history against medicines
11. doctors' stop not to register to the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ikenaga Masakazu,Nakamori Seiji |
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 | 22 | 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
| 2004 | Year | 07 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 06 | Month | 14 | 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=R000000889
