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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013082
Receipt No. R000015186
Scientific Title A phase II trial of palonosetron and 1-day dexamethasone and 3-day aprepitant to prevent nausea and vomiting in patients receiving paclitaxel and carboplatin
Date of disclosure of the study information 2014/02/05
Last modified on 2017/02/09

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Basic information
Public title A phase II trial of palonosetron and 1-day dexamethasone and 3-day aprepitant to prevent nausea and vomiting in patients receiving paclitaxel and carboplatin
Acronym PALODEX-A trial
Scientific Title A phase II trial of palonosetron and 1-day dexamethasone and 3-day aprepitant to prevent nausea and vomiting in patients receiving paclitaxel and carboplatin
Scientific Title:Acronym PALODEX-A trial
Region
Japan

Condition
Condition patients receiving paclitaxel and carboplatin for gynecologic malignancies
Classification by specialty
Medicine in general
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the efficacy of aprepitant and palonosetron and dexamethasone in patients receiving pal\clitaxel and carboplatin for gynecologic malignancies.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The rate of delayed complete response (CR), defined as no vomiting with no rescue
medication for 24-120 h from the start of the first cycle of paclitaxel and carboplatin.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 day1 aprepitant 125mg + palonosetron 0.75mg + dexamethazone20mg
day2 aprepitant 80mg
day3 aprepitant 80mg
Interventions/Control_2
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.Age >=20 years old
2.Gynecological malignacies confirmed by histology.
3.No previous history of receiving chemotherapy.
4.Receiving paclitaxel175mg/m2 plus carboplatin AUC=5.
5.Adequate bone marrow,liver,and renal functions.
WBC >=3000/mm3
Hb >=9.0g/dl
Platelet >=100000/mm3
AST, ALT=<100IU/l
Total bilirubin=<1.5mg/dl
Creatinin=<1.2mg/dl
6.Performance Status 0-1
7.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 aprepitant and / or palonosetron and / or other 5-HT3 receptor antagonists and / or Hypersensitivity to have a history dexamethazone. .
8.Receiving pimozide
9.Pregnancy or lactation.
10.Previous history of receiving aprepitant and / or palonosetron.
11.Patient who doesn't have ability or intention that cooperates for procedure of the study
12.Inappropriate patients for this study judged by the physicians
Target sample size 70

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 furunao@naramed-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Fuminori Ito
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 f_ito_0624@yahoo.co.jp

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
2014 Year 02 Month 05 Day

Related information
URL releasing protocol
Publication of results Published

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
2014 Year 01 Month 29 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 05 Day
Last follow-up date
2016 Year 02 Month 28 Day
Date of closure to data entry
2016 Year 03 Month 01 Day
Date trial data considered complete
2016 Year 03 Month 14 Day
Date analysis concluded
2016 Year 07 Month 18 Day

Other
Other related information

Management information
Registered date
2014 Year 02 Month 05 Day
Last modified on
2017 Year 02 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015186

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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