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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007491
Receipt No. 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

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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
Obsterics 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
Email

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
Email furunao0813@gmail.com

Sponsor
Institute Nara Medical University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008827

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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