UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Naoto Furukawa
Organization	Nara Medical University
Division name	Department of Obstetrics and Gynecology
Address	840 Shijo-cho, Kashihara
TEL	0744-22-3051
Email	furunao@naramed-u.ac.jp

Public contact
Name of contact person	Fuminori Ito
Organization	Nara Medical University
Division name	Department of Obstetrics and Gynecology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 01 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000015186