UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007491 |
|---|---|
| Receipt number | R000008827 |
| Scientific Title | Clinical evaluation of two antiemetic combinations palonosetron dexamethazone in paclitaxel and carboplatin: a randomized phase II trial. |
| Date of disclosure of the study information | 2012/04/01 |
| Last modified on | 2014/01/07 17:20:33 |
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Basic information
Public title
Clinical evaluation of two antiemetic combinations palonosetron dexamethazone in paclitaxel and carboplatin: a randomized phase II trial.
Acronym
PALODEX
Scientific Title
Clinical evaluation of two antiemetic combinations palonosetron dexamethazone in paclitaxel and carboplatin: a randomized phase II trial.
Scientific Title:Acronym
PALODEX
Region
| Japan |
Condition
Condition
patients with gynecological malignancies who are receiving paclitaxel/carboplatin.
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the efficacy and tolerability of palonpsetron in combination with 1-day dexamethasone versus 3-day dexamethazone in patients with gynecologiccal malignancies who are receiving paclitaxel and carboplatin.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The primary endpoint is complete response(
no emetic episodes and no rescue medication) in delayed chemotherapy-induced nausea and vomiting.
Key secondary outcomes
The secondary endpoints are complete response in acute and overall chemotherapy-induced nausea and vomiting, and complete cntrol( no emetic episodes, no use of rescue medication, and no nausea), grade of nausea, and incidence of side effects in acute, delayed and overall chemotherapy-induced nausea and vomiting.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
day1 palonosetron0.75mg plus dexamethazone20mg
day2,3 dexametazone8mg
Interventions/Control_2
day1 palonosetron0.75mg plus dexamethazone20mg
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.Gynecological malignacies confirmed by histology.
2.No previous history of receiving chemotherapy.
3.Receiving paclitaxel175mg/m2 plus carboplatin AUC=5.
4.Adequate bone marrow,liver,and renal functions.
5.Performance Status 0-1
6.written informed consent
Key exclusion criteria
1.Serious complication as followings; interstitial pneumonia; pulmonary fibrosis; heartfailure; renal failure; hepatic failure; uncontrolled diabetes mellitus etc.
2.Patients with symptomatic brain metastasis.
3.Receiving antiseizure medications.
4.Severe ascites and / or pleural effusion.
5.Bowel obstruction.
6.Symptom of emesis.
7.Hypersensitivity to have a history palonosetron and / or other 5-HT3 receptor antagonists.
8.Hypersensitivity to have a history dexamethazone.
9.Pregnancy or lactation.
10.Previous history of receiving palonosetron.
11.Inappropriate patients for this study judged by the physicians
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoto Furukawa |
Organization
Nara Medical University
Division name
Department of Obstetrics and Gynecology
Zip code
Address
840 Shijo-cho, Kashihara
TEL
0744-22-3051
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoto Furukawa |
Organization
Nara Medical University
Division name
Department of Obstetrics and Gynecology
Zip code
Address
840 Shijo-cho, Kashihara
TEL
0744-22-3051
Homepage URL
furunao0813@gmail.com
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
| 2012 | 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
| 2012 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 01 | Month | 07 | Day |
Date of closure to data entry
| 2014 | Year | 01 | Month | 07 | Day |
Date trial data considered complete
| 2014 | Year | 01 | Month | 07 | Day |
Date analysis concluded
| 2014 | Year | 01 | Month | 07 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 03 | Month | 13 | Day |
Last modified on
| 2014 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008827
