Unique ID issued by UMIN | UMIN000010046 |
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Receipt number | R000011764 |
Scientific Title | A randomized pilot study to search the predictive parameters of PSK responder in patients with colorectal cancer |
Date of disclosure of the study information | 2013/02/14 |
Last modified on | 2013/09/09 12:57:06 |
A randomized pilot study to search the predictive parameters of PSK responder in patients with colorectal cancer
A randomized pilot study to search the predictive parameters of PSK responder in patients with colorectal cancer
A randomized pilot study to search the predictive parameters of PSK responder in patients with colorectal cancer
A randomized pilot study to search the predictive parameters of PSK responder in patients with colorectal cancer
Japan |
colorectal cancer
Gastrointestinal surgery |
Malignancy
YES
Patients with Stage II/III colorectal cancer received adjuvant immnochemotherapy after curative resection using UFT (Stage II) or UFT/LV (Stage III) combined with PSK for 1 year. The purpose of this study is to search the predictive parameters of PSK responder in patients with colorectal cancer according to the polymorphisms of cytokine promotor.
Efficacy
3 years disease free survival
Interventional
Parallel
Randomized
Open -no one is blinded
Active
2
Treatment
Medicine | Maneuver |
1)Curative resection
2)UFT (Stage II) or UFT/LV (Stage III) for 1 year
1)Curative resection
2)UFT (Stage II) or UFT/LV (Stage III) combined with PSK for 1 year
20 | years-old | <= |
80 | years-old | > |
Male and Female
1)Histologically proven adenocarcinoma of colon cancer.
2)Patients with Stage II, III and recieved curative resection.
3)No prior radiotherapy, chemotherapy.
4)Age of 20 years or older, 79 years or younger.
5)ECOG Performance status:0-2.
6)Adequate organ functions:
without watery diarrhea
WBC >=3000/mm3,
platelets >=100,000/mm3,
AST(GOT)/ALT(GPT) <=100IU/L,
total bilirubin <=2.0mg/dL,
creatinine <=UNL.
7)Written informed consent.
1)Patients with non-curative resection.
2)Patients with anal canal cancer.
3)Patients with GI stricture.
4)A large amount of pleural effusion or peritoneal fluid.
5)Infection
6)Active synchronous malignancy.
7)Pregnant females, possibly pregnant
females, females wishing to become pregnant and nursing mothers.
8)Severe complications, such as uncontrolled diabetes mellitus.
9)Severe complications, such as heart failure.
10)Severe mental disorders.
11)Patients under treatment with steroid.
12)Other patients who are unfit for the study as determined by the attending physician.
210
1st name | |
Middle name | |
Last name | Masaaki Oka |
Yamaguchi University Graduate School of Medicine
Department of Digestive Surgery and Surgical Oncology
1-1-1 Minamikokushi, Ube, Yamaguchi 755-8505, Japan
0836-22-2264
sigefumi@yamaguchi-u.ac.jp
1st name | |
Middle name | |
Last name | Shigefumi Yoshino |
Yamaguchi University Graduate School of Medicine
Department of Digestive Surgery and Surgical Oncology
1-1-1 Minamikokushi, Ube, Yamaguchi 755-8505, Japan
0836-22-2264
sigefumi@yamaguchi-u.ac.jp
Department of Digestive Surgery and Surgical Oncology, Yamaguchi University Graduate School of Medicine
Department of Digestive Surgery and Surgical Oncology, Yamaguchi University Graduate School of Medicine
Other
NO
2013 | Year | 02 | Month | 14 | Day |
Unpublished
Open public recruiting
2010 | Year | 04 | Month | 21 | Day |
2010 | Year | 05 | Month | 01 | Day |
2017 | Year | 10 | Month | 31 | Day |
2013 | Year | 02 | Month | 14 | Day |
2013 | Year | 09 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011764
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