UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016681
Receipt number R000019357
Scientific Title Effect of Goreisan in preventing or reducing diarrhea in patients receiving concurrent chemoradiotherapy for cervical cancer
Date of disclosure of the study information 2015/03/02
Last modified on 2019/04/23 09:46:35

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Basic information

Public title

Effect of Goreisan in preventing or reducing diarrhea in patients receiving concurrent chemoradiotherapy for cervical cancer

Acronym

Effect of Goreisan in preventing or reducing chemoradiation-induced diarrhea

Scientific Title

Effect of Goreisan in preventing or reducing diarrhea in patients receiving concurrent chemoradiotherapy for cervical cancer

Scientific Title:Acronym

Effect of Goreisan in preventing or reducing chemoradiation-induced diarrhea

Region

Japan


Condition

Condition

cervical cancer

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to investigate the efficacy and safety of Goreisan for preventing diarrhea during radiation therapy in patients with cervical cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Occurrence rate of >grade 2 diarrhea as measured by the Common Terminology Criteria for Adverse Events v4.0.

Key secondary outcomes

1) Protection period of diarrhea (total treatment duration - total days of >grade 2 diarrhea / total treatment duration);
2) Time to the first occurrence of >grade 2 diarrhea from the first day of treatment;
3) Adverse effects;
4) Frequency of diarrhea and transition of the grade of diarrhea.


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

Goreisan 7.5g per day

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

70 years-old >

Gender

Female

Key inclusion criteria

1) Histologically confirmed uterine cervical cancer of clinical stage IB2-IVa in whom cisplatin-based CCRT was planned as both primary and adjuvant treatments
2) Age >20 years, <75 years;
3) Performance status =<2;
4) With written informed consent obtained before participation;
5) No prior radiother

Key exclusion criteria

1) Inflammatory bowel disease such as Crohn disease and ulcerative colitis
2) Severe hepatic dysfunction (aspartate aminotransferase or alanine aminotransferase >=100 U/L)
3) Severe renal dysfunction (serum creatinine >=1.5 mg/dL or blood urea nitrogen >=25 mg/dL)
4) Mental illness that may require the administration of antipsychotics, and dementia
5) Current use of other oriental medicine
6) A history of the hypersensitivity that is serious for the study medicine, or drug allergy
7) Any case that the chief physician judges to be inadequate.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name AKIRA
Middle name
Last name Mitsuhashi

Organization

Graduate School of Medicine, Chiba University

Division name

Reproductive Medicine

Zip code

260-8670

Address

1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan

TEL

043-222-7171

Email

antira@faculty.chiba-u.jp


Public contact

Name of contact person

1st name Sinsuke
Middle name
Last name Hanawa

Organization

Chiba University Hospital

Division name

Gynecology

Zip code

260-8670

Address

1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan

TEL

043-222-7171

Homepage URL


Email

hanawa-shinsuke@chiba-u.jp


Sponsor or person

Institute

Chiba University Hospital

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Chiba University Hospital Institutional Review Board

Address

1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan

Tel

043-222-7171

Email

hanaoka.hideki@faculty.chiba-u.jp


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

2015 Year 03 Month 02 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

Terminated

Date of protocol fixation

2014 Year 10 Month 19 Day

Date of IRB

2014 Year 12 Month 17 Day

Anticipated trial start date

2015 Year 03 Month 02 Day

Last follow-up date

2018 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 03 Month 02 Day

Last modified on

2019 Year 04 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019357


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name