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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031159
Receipt No. 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

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Basic information
Public title Preventive effect of Bushimatsu and Keishikajubutou on peripheral neurotoxicity of Oxaliplatin(L-OHP) therapy: a phase II clinical study.
Acronym Preventive effect of Bushimatsu and Keishikajubutou on peripheral neurotoxicity of Oxaliplatin(L-OHP) therapy: a phase II clinical study.
Scientific Title Preventive effect of Bushimatsu and Keishikajubutou on peripheral neurotoxicity of Oxaliplatin(L-OHP) therapy: a phase II clinical study.
Scientific Title:Acronym Preventive effect of Bushimatsu and Keishikajubutou on peripheral neurotoxicity of Oxaliplatin(L-OHP) therapy: a phase II clinical study.
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 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
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety and efficacy of Keishi Kamisukutou (TJ - 18) + bushi-matsu (TJ - 3023) for oxaliplatin-induced peripheral neuropathy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 administration of keishi kajutubu tou (TJ - 18) + Bushi matsu (TJ - 3023)
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

Not applicable
Gender Male and Female
Key inclusion criteria (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
Key exclusion criteria (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
Target sample size 32

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroki Yamaue
Organization Wakayama Medical University
Division name Second Department of Surgery
Zip code
Address 811-1, Kimiidera, Wakayama, JAPAN
TEL 073-441-0613
Email hiwa@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiromitsu Iwamoto
Organization Wakayama Medical University
Division name Second Department of Surgery
Zip code
Address 811-1, Kimiidera, Wakayama, JAPAN
TEL 073-441-0613
Homepage URL
Email hiwa@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

Funding Source
Organization self funding
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
Email

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
2018 Year 02 Month 05 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 Enrolling by invitation
Date of protocol fixation
2017 Year 11 Month 27 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 02 Month 05 Day
Last modified on
2018 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034706

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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