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
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
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
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
