UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000841 |
|---|---|
| Receipt number | R000001011 |
| Scientific Title | Phase II study of second-line chemotherapy using modified FOLFOX6 in patients with advanced/ recurrent colorectal cancer (OGSG 0505) |
| Date of disclosure of the study information | 2007/10/11 |
| Last modified on | 2021/11/15 23:05:24 |
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Basic information
Public title
Phase II study of second-line chemotherapy using modified FOLFOX6 in patients with advanced/ recurrent colorectal cancer (OGSG 0505)
Acronym
OGSG 0505
Scientific Title
Phase II study of second-line chemotherapy using modified FOLFOX6 in patients with advanced/ recurrent colorectal cancer (OGSG 0505)
Scientific Title:Acronym
OGSG 0505
Region
| Japan |
Condition
Condition
Patients with unresectable or metastatic colon cancer registant to fluorouracil treatment
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A mFOLFOX treatment is evaluated in terms of response rate and adverse events for patients with unresectable or metastatic colon cancer who underwent fluorouracil treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response Rate(RECIST), Duration of response
Key secondary outcomes
Overall Survival, Feasibility Adverse Events
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
DAY 1 day 2 day 14
L-OHP
2HR
l-LV 200mg/m2 5-FU 2,400mg/m2 civ
2HR 46HR .......
|
5-FU 400mg/m2 iv
Rapid
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) colon cancer proven histologically
2) unresectable or metastatic colon cancer
3) with prior chemotherapy of fluoropyrimidine
O the last prior therapy before more than 4 weeks of registration
O without L-OHP therapy
O For patients with postoperative adjuvant chemotherapy, progression is observed on x-ray examination or tumor marker examination within 26 weeks of adjuvant chemotheray.
4) with measurable metastatic lesions
5) age: =>20 and 75=>
6) Performance Status: 0-1 (ECOG criteria)
7) more than 12 weeks of expected survival period
8) sufficient function of important organs
O WBC: >= 4,000 and =< 12,000/mm3
O Platelet: >= 100,000/mm3
O sGOT,sGPT: 2.5 times of normal range in each institute
O sT.bil.: <= 1.5 mg/dl
O sCreatinin: <= upper limit of each institute
O ECG: normal range
9) written informed consent
Key exclusion criteria
"1) Cavity fluid which needs drainage
2) with active double cancer except ca. in situ
3) with peripheral nerve disorder
4) with infectious disease which needs treatment
5) under watery diarrhea
6) with mental disorder which disturbs registration to this study
7) patients who receive steroids treatment
8) Cardiac failure, liver dysfunction, or renal dysfunction which disturb
Registration to this study
9) pregnant women or women who like to be pregnant
10) history of severe allergy against drug
11) doctor's dicision not to be registered to this study"
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mishima Hideyuki |
Organization
National Hospital Orgamnzation
Osaka Medical Center
Division name
Dpt.Surgery
Zip code
Address
2-1-14.Houenzaka, chuo-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
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 | 10 | Month | 11 | 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
| 2005 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 04 | 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 | 10 | Month | 04 | 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=R000001011
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