UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005317
Receipt No. R000006320
Scientific Title Effect of oral neurokinin-1 antagonist, aprepitant for chemotherapy-induced nausea and vomiting in patients with gynecologic cancer receiving carboplatin/paclitaxel chemotherapy.
Date of disclosure of the study information 2011/03/31
Last modified on 2011/03/25

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effect of oral neurokinin-1 antagonist, aprepitant for chemotherapy-induced nausea and vomiting in patients with gynecologic cancer receiving carboplatin/paclitaxel chemotherapy.
Acronym Effect of oral neurokinin-1 antagonist, aprepitant for chemotherapy-induced nausea and vomiting in patients with gynecologic cancer receiving carboplatin/paclitaxel chemotherapy.
Scientific Title Effect of oral neurokinin-1 antagonist, aprepitant for chemotherapy-induced nausea and vomiting in patients with gynecologic cancer receiving carboplatin/paclitaxel chemotherapy.
Scientific Title:Acronym Effect of oral neurokinin-1 antagonist, aprepitant for chemotherapy-induced nausea and vomiting in patients with gynecologic cancer receiving carboplatin/paclitaxel chemotherapy.
Region
Japan

Condition
Condition gynecologic cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of aprepitant with 5-HT3 receptor antagonist and dexamethasone for chemotherapy-induced nausea and vomiting in patients with gynecologic cancer receiving their first course of carboplatin/paclitaxel chemotherapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The proportion of patients with Complete Response (no vomiting and no use of rescue therapy) during overall phase (5 days following initiation of chemotherapy) in first cycle.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Aprepitant 125mg PO on day 1
Aprepitant 80mg PO on days 2 to 3
Granisetron 3mg IV on day 1
Dexamethasone 16mg or 8mg IV on day 1
Dexamethasone 4mg PO on days 2 to 3
Interventions/Control_2 Granisetron 3mg IV on day 1
Dexamethasone 16mg or 8mg IV on day 1
Dexamethasone 8mg PO on days 2 to 3
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 Female
Key inclusion criteria 1) Patient is 20 years and over
2) Gynecologic cancer patients who are scheduled to receive their first course of TC regimen (Carboplatin/Paclitaxel) chemotherapy
Key exclusion criteria 1) Patient has a serious hepatic insufficiency or renal failure
2) Patient has nausea or vomiting within 24 hours prior to chemotherapy
3) Patient has been treated with antiemetic agents within 48 hours prior to chemotherapy
4) Patient has any illness (e.g. central nervous system tumors, gastrointestinal obstruction, active peptic ulcer, brain metastasis) caused nausea or vomiting except for chemotherapy-induced nausea and vomiting
5) Patient is unable to be administered dexamethasone for 3 days due to associated illnesses such as out-of-control diabetes mellitus
6) Patient is receiving pimozide
7) Patient is judged inappropriate by the investigator as subject for this study
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Tsujioka
Organization Fukuoka University Hospital
Division name Department of gynecology
Zip code
Address 7-45-1 nanakuma, jonan-ku, fukuoka, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Fukuoka University Hospital
Division name Department of gynecology
Zip code
Address 7-45-1 nanakuma, jonan-ku, fukuoka, Japan
TEL 092-801-1011
Homepage URL
Email

Sponsor
Institute Department of gynecology, Fukuoka 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
2011 Year 03 Month 31 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 Open public recruiting
Date of protocol fixation
2010 Year 11 Month 29 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 01 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
2011 Year 03 Month 25 Day
Last modified on
2011 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006320

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.