UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031159
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

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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 or person

Institute

Wakayama Medical University

Institute

Department

Personal name



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

Value
https://center6.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