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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000009585
Receipt No. R000011248
Scientific Title Phase III study to clarify the efficacy and safety of aprepitant or palonosetron on chemotherapy with paclitaxel and carboplatin for gynecologic cancer
Date of disclosure of the study information 2013/03/01
Last modified on 2012/12/19

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Basic information
Public title Phase III study to clarify the efficacy and safety of aprepitant or palonosetron on chemotherapy with paclitaxel and carboplatin for gynecologic cancer
Acronym Phase III study to clarify the efficacy and safety of aprepitant or palonosetron on chemotherapy with paclitaxel and carboplatin for gynecologic cancer
Scientific Title Phase III study to clarify the efficacy and safety of aprepitant or palonosetron on chemotherapy with paclitaxel and carboplatin for gynecologic cancer
Scientific Title:Acronym Phase III study to clarify the efficacy and safety of aprepitant or palonosetron on chemotherapy with paclitaxel and carboplatin for gynecologic cancer
Region
Japan

Condition
Condition Cervical cancer, Corpus cancer, Ovarian cancer, Tubal cancer, Peritoneal cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the efficacy and safety of aprepitant or palonosetron for chemotherapy with Paclitaxel and Carboplatin
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Anti emetic efficacy for 5 days after chemotherapy
Key secondary outcomes 1. Anti emetic efficacy on the day of chemotherapy
2. Anti-emetic efficacy during day2 to 5 after chemotherapy
3. Ratio of emesis, vomiting and rescue therapy for 5 days after chemotherapy
4. Time until rescue therapy
5. Food intake after chemotherapy
6. Influence of risk factor (Background of patient)
7. Total amount for anti emetic therapy
8. Influence by difference of the schedule of carboplatin and Paclitaxel
9. Change the efficacy on several courses
10. Efficacy of rescue therapy with aprepitant or palonosetron

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 and granisetron and dexamethasone
Interventions/Control_2 Palonosetron and dexamethasone
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
80 years-old >
Gender Female
Key inclusion criteria Gynecologic cancer patients necessary the chemotherapy with paclitaxel and carboplatin
Key exclusion criteria 1. Past history of previous chemotherapy
2. Hypersensitivity for Aprepitant or Palonosetron
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Minoru Irahara
Organization Tokushima University Hospital
Division name Obstetris and Gynecology
Zip code
Address 3-18-15 Kurmoto-cho Tokushima
TEL 088-633-7177
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masato Nishimura
Organization Tokushima University Hospital
Division name Obstetrics and Gynecology
Zip code
Address 3-18-15 Kuramoto-cho Tokushima
TEL 088-633-7177
Homepage URL
Email

Sponsor
Institute Obstetrics and Gynecology, Tokushima 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
2013 Year 03 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 Preinitiation
Date of protocol fixation
2013 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date
2013 Year 03 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
2012 Year 12 Month 19 Day
Last modified on
2012 Year 12 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011248

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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