Unique ID issued by UMIN | UMIN000003552 |
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Receipt number | R000004307 |
Scientific Title | Multicenter Phase II Study of Epitope Peptides with UFT/LV following curative resection for stage III Colorectal cancer |
Date of disclosure of the study information | 2010/04/28 |
Last modified on | 2013/04/30 18:37:10 |
Multicenter Phase II Study of Epitope Peptides with UFT/LV following curative resection for stage III Colorectal cancer
Multicenter Phase II Study of Epitope Peptides with UFT/LV following curative resection for stage III Colorectal cancer
Multicenter Phase II Study of Epitope Peptides with UFT/LV following curative resection for stage III Colorectal cancer
Multicenter Phase II Study of Epitope Peptides with UFT/LV following curative resection for stage III Colorectal cancer
Japan |
Stage III colorectal cancer
Gastrointestinal surgery |
Malignancy
NO
To determine the efficacy and safety of the combination therapy with UFT/LV and novel epitope peptides following curative resection for stage III colorectal cancer.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
recurrence rate
safety
immune response
Interventional
Parallel
Randomized
Cluster
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
NO
No need to know
2
Treatment
Medicine |
HLA-A2402 positive
HLA-A2402 negative
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1. Histological proven stage III colorectal cancer
2. PS:0 to 1(ECOG performance status score)
3. 20-80 years old
4. Good function of critical organs
5. Written informed consents
1.Plegnant
2. Breastfeeding
3. Wish for pregnancy
4. Active infection
5. Steroid or immunosuppressive therapy
6. Multiple cancer
7. Doctors opinion
110
1st name | |
Middle name | |
Last name | Kiyotaka Okuno |
Kinki University School of Medicine
Department of Surgery
377-2 Ohnohigashi, Osakasayama, Osaka 589-8511, Japan
1st name | |
Middle name | |
Last name | Fumiaki Sugiura |
Kinki University School of Medicine
Department of Surgery
377-2 Ohnohigashi, Osakasayama, Osaka 589-8511, Japan
Kinki University School of Medicine
Department of Surgery
NEDO
NO
2010 | Year | 04 | Month | 28 | Day |
Unpublished
Enrolling by invitation
2009 | Year | 12 | Month | 18 | Day |
2010 | Year | 02 | Month | 01 | Day |
2010 | Year | 04 | Month | 28 | Day |
2013 | Year | 04 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004307
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