UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009585 |
|---|---|
| Receipt number | 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 22:24:36 |
* 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
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
| Obstetrics 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
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
Sponsor or person
Institute
Obstetrics and Gynecology, Tokushima University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011248
