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 |
Phase II study of second-line chemotherapy using modified FOLFOX6 in patients with advanced/ recurrent colorectal cancer (OGSG 0505)
OGSG 0505
Phase II study of second-line chemotherapy using modified FOLFOX6 in patients with advanced/ recurrent colorectal cancer (OGSG 0505)
OGSG 0505
Japan |
Patients with unresectable or metastatic colon cancer registant to fluorouracil treatment
Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Malignancy
NO
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.
Safety,Efficacy
Response Rate(RECIST), Duration of response
Overall Survival, Feasibility Adverse Events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
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
20 | years-old | <= |
75 | years-old | >= |
Male and Female
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
"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"
50
1st name | |
Middle name | |
Last name | Mishima Hideyuki |
National Hospital Orgamnzation
Osaka Medical Center
Dpt.Surgery
2-1-14.Houenzaka, chuo-ku, Osaka, 540-0006
06-6942-1331
1st name | |
Middle name | |
Last name | Furukawa Hiroshi |
Sakai City Hospital
Director
1-1-1,Minamiyasuicho,Sakai-ku,Sakai, 590-0064
OGSG
NPO Osaka Chinical Study Supporting Organization
Self funding
NO
2007 | Year | 10 | Month | 11 | Day |
Unpublished
Completed
2005 | Year | 06 | Month | 01 | Day |
2005 | Year | 06 | Month | 01 | Day |
2007 | Year | 04 | Month | 01 | Day |
2007 | Year | 04 | Month | 01 | Day |
2008 | Year | 08 | Month | 01 | Day |
2008 | Year | 08 | Month | 01 | Day |
2007 | Year | 10 | Month | 04 | Day |
2021 | Year | 11 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001011
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