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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026739
Receipt No. R000030694
Scientific Title The efficacy and safety of antiemetic therapy for carboplatin-containing chemotherapy-induced nausea and vomiting in patients with lung cancer.
Date of disclosure of the study information 2017/04/01
Last modified on 2019/03/08

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Basic information
Public title The efficacy and safety of antiemetic therapy for carboplatin-containing chemotherapy-induced nausea and vomiting in patients with lung cancer.
Acronym Antiemetic therapy for carboplatin-containing chemotherapy-induced nausea and vomiting.
Scientific Title The efficacy and safety of antiemetic therapy for carboplatin-containing chemotherapy-induced nausea and vomiting in patients with lung cancer.
Scientific Title:Acronym Antiemetic therapy for carboplatin-containing chemotherapy-induced nausea and vomiting.
Region
Japan

Condition
Condition advanced lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of aprepitant, 5-HT3 receptor antagonist, dexamethasone, and olanzapine to prevent carboplatin-containing chemotherapy-induced nausea and vomiting.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Complete response rate during the 120 h after carboplatin administration.
Key secondary outcomes Complete response rate during the acute, delayed phase. Complete control rate, safety.

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 No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 aprepitant, 5-HT3 receptor antagonist, dexamethasone, olanzapine
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)advanced lung cancer patients who receive carboplatin containing chemotherapy
2)20 years old or older.
3)performance status 0-2.
4)written informed consent.
Key exclusion criteria 1)patients with the history of hypersensitivity or allergy for study drugs.
2)patients who need and use antiemetic therapy during 48h before chemotherapy.
3)patients with severe hepatic or renal dysfunction.
4)With convulsion.
5)Patients who need puncture to manage ascites.
6)Patients with complications inducing nausea and vomiting.
7)Patients with diabetes mellitus.
8)Patients who are judged to be inappropriate for this study.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takafumi Suda
Organization Hamamatsu university school of medicine
Division name Second Division, Department of Internal Medicine
Zip code
Address 1-20-1, Handayama, Higashi-ku, Hamamatsu-shi, Shizuoka
TEL 053-435-2263
Email suda@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuki Tanaka
Organization Hamamatsu university school of medicine
Division name Second Division, Department of Internal Medicine
Zip code
Address 1-20-1, Handayama, Higashi-ku, Hamamatsu-shi, Shizuoka
TEL 053-435-2263
Homepage URL
Email 41231644@hama-med.ac.jp

Sponsor
Institute Second Division, Department of Internal Medicine, Hamamatsu university school of medicine
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 浜松医科大学医学部付属病院(静岡県), 磐田市立総合病院(静岡県), 藤枝市立総合病院(静岡県), 聖隷浜松病院(静岡県), 聖隷三方原病院(静岡県), 静岡県立総合病院(静岡県), 済生会静岡病院(静岡県)

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 01 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 Completed
Date of protocol fixation
2017 Year 01 Month 26 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
2018 Year 07 Month 19 Day
Date of closure to data entry
2018 Year 10 Month 25 Day
Date trial data considered complete
2018 Year 10 Month 25 Day
Date analysis concluded
2018 Year 12 Month 25 Day

Other
Other related information

Management information
Registered date
2017 Year 03 Month 28 Day
Last modified on
2019 Year 03 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030694

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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