UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013082 |
|---|---|
| Receipt number | 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 16:25:36 |
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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
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
f_ito_0624@yahoo.co.jp
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015186
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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