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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000009311
Receipt No. R000010786
Scientific Title The efficacy of fosaprepitant to the moderate emetic risk intravenous chemotherapy
Date of disclosure of the study information 2012/11/15
Last modified on 2013/05/22

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Basic information
Public title The efficacy of fosaprepitant to the moderate emetic risk intravenous chemotherapy
Acronym The efficacy of fosaprepitant to the moderate emetic risk intravenous chemotherapy
Scientific Title The efficacy of fosaprepitant to the moderate emetic risk intravenous chemotherapy
Scientific Title:Acronym The efficacy of fosaprepitant to the moderate emetic risk intravenous chemotherapy
Region
Japan

Condition
Condition Patients who are not effective by two antiemetic drugs(5-HT3 antagonist and dexamethasone) for the moderate emetic risk intravenous chemotherapy(L-OHP, CPT-11, CBDCA)
Classification by specialty
Gastroenterology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We research the situation of the digestive symptom(nausea and vomoiting) in patients who received moderate emetic risk intravenous chemotherapy and the efficacy of fosaprepitant to the patients who are not effective by two antiemetic drugs(5-HT3 antagonist and dexamethasone).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes >Patients rate who required triple-drug therapy because of a digestive symptom(nausea and vomiting)
>Improvement rate of the digestive symptom(nausea and vomiting) by the triple-drug therapy
Key secondary outcomes >Patients rate without vomiting
>Patients rate of Complete Response (without vomiting and rescue)
>Patients rate of Complete Protection (without vomiting, rescue, moderate or severe nausea)
>Patients rate without nausea
>Patients rate without moderate or severe nausea
>Frequency distribution of nausea and vomiting
>Successful treatment period
>Intake situation

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 We administer three antiemetic drugs(5-HT3 antagonist, dexamethasone and fosaprepitant) from the next course for the patients who experienced nausea and vomiting by two antiemetic drugs(5-HT3 antagonist and dexamethasone).
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)Patients who are not effective by two antiemetic drugs(5-HT3 antagonist and dexamethasone) for the moderate emetic risk intravenous chemotherapy(L-OHP, CPT-11, CBDCA)
2)We use palonosetron as 5-HT3 antagonist
3)Clinical stage: do not ask
4)Molecular target drug: do not ask
5)Documented informed consent
Key exclusion criteria 1)Serious complications (e.g. severe liver disfunction or renal disfunction)
2)Patients with factors besides chemotherapy(e.g. brain tumor, passage disorder of digestive tract, active digestive ulcer, brain metastases)
3)Poorly controlled diabetes
4)Pregnant or lactating women or women of childbearing potential
5)Patients during pimozide administration
6)Inadequate physical condition, as diagnosed by primary physician
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chikashi Ishioka
Organization Institute of Development, Aging and Cancer, Tohoku University
Division name Department of Clinical Oncology
Zip code
Address 4-1 Seiryo-machi, Aoba-ku, Sendai, Japan
TEL 022-717-8543
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masanobu Takahashi
Organization Tohoku University Hospital
Division name Department of Clinical Oncology
Zip code
Address 4-1 Seiryo-machi, Aoba-ku, Sendai, Japan
TEL 022-717-8543
Homepage URL http://www.co.idac.tohoku.ac.jp/
Email mtakahashi@idac.tohoku.ac.jp

Sponsor
Institute Division of Clinical Oncology, Tohoku University Hospital
Institute
Department

Funding Source
Organization None
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
2012 Year 11 Month 15 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
2012 Year 09 Month 14 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 15 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
2012 Year 11 Month 11 Day
Last modified on
2013 Year 05 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010786

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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