UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Palonosetron+Aprepitant+Dexamethasone for moderately emetic chemotherapy induced nausea and voimiting-Phase II study-
Title of the study (Brief title)	Palonosetron+Aprepitant+Dexamethasone for moderately emetic chemotherapy induced nausea and voimiting
Region	Japan

Condition
Condition	Lung cancer
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate efficacy and safety of Palonosetron+ Aprepitant + Dexamethasone in moderately emetic CINV in lung cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Complete response rate in 1st course of chemotherapy
Key secondary outcomes	Complete response rate in any course of chemotherapy Complete control rate Time to treatment failure QOL analysis Toxicity

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Aprepitant: 125mg po. 1-1.5 hr. prior to chemotherapy on Day1 Palonosetron:0.75mg iv. prior to chemotherapy on Day1 Dexamethasone: 4.95mg iv. 30 min. prior to chemotherapy on Day 1, 4mg po. on Day 2-3.
Interventions/Control_2	Granisetron or Ondansetron:1A iv. prior to chemotherapy on Day1 Dexamethasone: 9.9mg iv. 30 min. prior to chemotherapy on Day 1, 8mg po. on Day 2-3.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Histologically or cytologically proven Lung cancer 2)Moderately or Highly emetic chemotherapy 3)Patient receiving moderately emetic chemotherapy defined by NCCN guideline 2009, ver 1. 3) Written IC.
Key exclusion criteria	1)MEC administration except Day 1. 2)Radiation therapy 3)Contraindication of Dexamethasone 4)Symptomatic brain meta 5)Hypersensitivity for Palonosetron, Aprepitant, Dexamethasone 6)Vomiting episode prior to chemotherapy with 24 hours
Target sample size	160

Research contact person
Name of lead principal investigator	Hirohisa Yoshizawa
Organization	Niigata University Medical and Dental Hospital
Division name	Bioscience Medical Research Center
Address	1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520
TEL	025-227-2517
Email	hy0522@med.niigata-u.ac.jp

Public contact
Name of contact person	Hirohisa Yoshizawa
Organization	Niigata University Medical and Dental Hospital
Division name	Bioscience Medical Research Center
Address	1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520
TEL	025-227-2517
Homepage URL
Email	hy0522@med.niigata-u.ac.jp

Sponsor
Institute	Niigata Lung Cancer Treatment Group
Institute
Department

Funding Source
Organization	Niigata Foundation of the Promotion of Medicine
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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	新潟肺癌治療研究会参加施設 新潟大学医歯学総合病院 新潟県立がんセンター新潟病院 鶴岡市立荘内病院 新潟市民病院 新潟県立新発田病院 佐渡総合病院 南部郷総合病院 厚生連長岡中央綜合病院 厚生連三条総合病院 厚生連刈羽郡総合病院 長岡赤十字病院 厚生連豊栄病院 済生会新潟第二病院 国立病院機構西新潟中央病院 新潟県立中央病院 新潟県立柿崎病院 燕労災病院 上越総合病院 新潟県立吉田病院

Other administrative information
Date of disclosure of the study information	2011 Year 01 Month 24 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2010 Year 12 Month 10 Day
Anticipated trial start date	2011 Year 01 Month 01 Day
Last follow-up date	2014 Year 01 Month 01 Day
Date of closure to data entry	2014 Year 02 Month 01 Day
Date trial data considered complete	2014 Year 03 Month 01 Day
Date analysis concluded	2014 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 01 Month 24 Day
Last modified on	2018 Year 06 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005877