Unique ID issued by UMIN | UMIN000031159 |
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Receipt number | R000034706 |
Scientific Title | Preventive effect of Bushimatsu and Keishikajubutou on peripheral neurotoxicity of Oxaliplatin(L-OHP) therapy: a phase II clinical study. |
Date of disclosure of the study information | 2018/02/05 |
Last modified on | 2018/02/05 22:01:45 |
Preventive effect of Bushimatsu and Keishikajubutou on peripheral neurotoxicity of Oxaliplatin(L-OHP) therapy: a phase II clinical study.
Preventive effect of Bushimatsu and Keishikajubutou on peripheral neurotoxicity of Oxaliplatin(L-OHP) therapy: a phase II clinical study.
Preventive effect of Bushimatsu and Keishikajubutou on peripheral neurotoxicity of Oxaliplatin(L-OHP) therapy: a phase II clinical study.
Preventive effect of Bushimatsu and Keishikajubutou on peripheral neurotoxicity of Oxaliplatin(L-OHP) therapy: a phase II clinical study.
Japan |
colorectal cancer
Gastrointestinal surgery |
Malignancy
NO
Evaluation of safety and efficacy of dose regulatory toxicity (DLT) , maximum tolerated dose (MTD) and recommended dose (RD) of prevention regimen (TJ - 18 + TJ - 3023) for colorectal stage II and stage III patients with oxaliplatin-induced peripheral neuropathy
Safety,Efficacy
Safety and efficacy of Keishi Kamisukutou (TJ - 18) + bushi-matsu (TJ - 3023) for oxaliplatin-induced peripheral neuropathy
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
administration of keishi kajutubu tou (TJ - 18) + Bushi matsu (TJ - 3023)
20 | years-old | <= |
Not applicable |
Male and Female
(1) Histologically confirmed colorectal cancer
(2) Patients with adjuvant chemotherapy for stage II and stage III colon cancer with curative resection
(3) Patients scheduled to undergo adjuvant chemotherapy including oxaliplatin
(4) Patients with age> 20 years (as of the registration date)
(5) ECOG PS of 0 or 1
(6) Patients with no major obstructions in major organs (bone marrow, heart, lungs, liver and kidney etc.)
(7) Patients with no prior chemotherapy for colorectal cancer
(8) Patients provided written informed consent before this study registration
(1) Patients with resistance to taking medicine for traditional Chinese medicine
(2) Patients with pre-treatment history of oxaliplatin
(3) Patients with duplicated active cancer
(4) Patients with severe dysesthesia or dysesthesia with dysfunction
(5) Patients with a history of severe drug hypersensitivity
(6) Patients with clinically problematic infection
(7) Patients in which it was judged that registration in this study was difficult due to clinically problematic mental / neurological diseases
(8) Patients with any of the following complications
i) diabetes with poor control
ii) hypertension with poor control
iii) interstitial pneumonia or pulmonary fibrosis
iv) intestinal palsy or intestinal obstruction
v) clinically problematic heart disease
(9) Other patients that the doctor in charge judged unsuitable for safely carrying out this study
32
1st name | |
Middle name | |
Last name | Hiroki Yamaue |
Wakayama Medical University
Second Department of Surgery
811-1, Kimiidera, Wakayama, JAPAN
073-441-0613
hiwa@wakayama-med.ac.jp
1st name | |
Middle name | |
Last name | Hiromitsu Iwamoto |
Wakayama Medical University
Second Department of Surgery
811-1, Kimiidera, Wakayama, JAPAN
073-441-0613
hiwa@wakayama-med.ac.jp
Wakayama Medical University
self funding
Self funding
NO
2018 | Year | 02 | Month | 05 | Day |
Unpublished
Enrolling by invitation
2017 | Year | 11 | Month | 27 | Day |
2018 | Year | 01 | Month | 01 | Day |
2018 | Year | 02 | Month | 05 | Day |
2018 | Year | 02 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034706
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