UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014239
Receipt number R000016586
Scientific Title Randomized phase II study of rikkunshito on chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy for lung cancer (HOT1402)
Date of disclosure of the study information 2014/06/13
Last modified on 2016/06/12 10:24:14

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Basic information

Public title

Randomized phase II study of rikkunshito on chemotherapy-induced
nausea and vomiting in patients receiving highly emetogenic
chemotherapy for lung cancer (HOT1402)

Acronym

Phase II study of rikkunshito on CINV in patients receiving HEC for lung cancer

Scientific Title

Randomized phase II study of rikkunshito on chemotherapy-induced
nausea and vomiting in patients receiving highly emetogenic
chemotherapy for lung cancer (HOT1402)

Scientific Title:Acronym

Phase II study of rikkunshito on CINV in patients receiving HEC for lung cancer

Region

Japan


Condition

Condition

Lung Cancer

Classification by specialty

Medicine in general Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of Rikkunshito on chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy for lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Complete response (no emesis, no retching, no rescue medication) rate in overall phase

Key secondary outcomes

Completer response (no emesis, no retching, no rescue medication) rate in acute/delayed phase, Complete protection [no emesis, no retching, no rescue medication, no significant nausea (VAS < 25mm)] rate in acute/delayed/overall phase, Total protection [(no emesis, no retching, no rescue medication, no nausea(VAS < 5mm)) rate in acute/delayed/overall phase, No emesis rate in acute/delayed/overall phase, No rescue medication rate in acute/delayed/overall phase, No significant nausea (VAS <25mm) rate in acute/delayed/overall phase, No nausea (VAS < 5mm) rate in acute/delayed/overall phase, Dietary intake in overall phase, Safety


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Standard antiemetic therapy recommended by each of the guidelines [National Comprehensive Cancer Network(NCCN), European Society for Medical Oncology, American Society of Clinical Oncology(ASCO), Japanese Society of Clinical Oncology(JSCO)]

Interventions/Control_2

Standard antiemetic therapy recommended by each of the guidelines [National Comprehensive Cancer Network(NCCN), European Society for Medical Oncology, American Society of Clinical Oncology(ASCO), Japanese Society of Clinical Oncology(JSCO)] with Rikkunsito

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)Age 20 or older
2)Histological or cytological confirmation of lung cancer
3)Cisplatin containing chemotherapy regimen
4)Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2
5)Laboratory test results within these ranges
1.White blood cell count=>3,000/ul or neutrophils=>1,500/ul
2.Hemoglobin=>9.0g/dl
3.Platelets=>100,000/ul
4.Total bilirubin<=1.5mg/dL
5.AST and ALT=<100IU/L
6.Creatinine=<1.5mg/dl
7.Coreatinin clearance=>60mL/min
8.PaO2=>60Torr or SpO2=>92%
6)A life expectancy=>2 months
7)Written informed consent

Key exclusion criteria

1)Drug allergy unfit for the study
2)Active infectious diseases
3)Severe complications (severe cardiac diseases, cerebrovascular diseases, active peptic ulcer, poorly controlled diabetes mellitus, clinically problematic, psycho-neurologic diseases)
4)Symptomatic brain metastasis
5)Active concomitant malignancy
6)Women who is lactating or pregnant or man who hope the pregnancy of the partner
7)Previous Rikkunshito therapy
8)Ineligible judgment by the physician

Target sample size

58


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshiyuki Harada, MD, PhD

Organization

Japan Community Health care Organization (JCHO) Hokkaido Hospital

Division name

Center for Respiratory Diseases

Zip code


Address

1-8-3-18, Nakanoshima, Toyohira-ku, Sapporo 062-8618, Japan

TEL

011-831-5151

Email

harada-toshiyuki@hokkaido.jcho.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshiyuki Harada, MD, PhD

Organization

Japan Community Health care Organization (JCHO) Hokkaido Hospital

Division name

Center for Respiratory Diseases

Zip code


Address

1-8-3-18, Nakanoshima, Toyohira-ku, Sapporo 062-8618, Japan

TEL

011-831-5151

Homepage URL


Email

harada-toshiyuki@hokkaido.jcho.go.jp


Sponsor or person

Institute

Hokkaido Lung Cancer Clinical Study Group

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


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

北海道肺癌臨床研究会関連施設、参加施設


Other administrative information

Date of disclosure of the study information

2014 Year 06 Month 13 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

No longer recruiting

Date of protocol fixation

2014 Year 05 Month 23 Day

Date of IRB


Anticipated trial start date

2014 Year 06 Month 13 Day

Last follow-up date

2016 Year 06 Month 30 Day

Date of closure to data entry

2016 Year 07 Month 31 Day

Date trial data considered complete

2016 Year 07 Month 31 Day

Date analysis concluded

2016 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2014 Year 06 Month 12 Day

Last modified on

2016 Year 06 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016586


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name