UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Placebo-controlled,double-blind,randomized study of comparing NK1 receptor antagonist/ palonosetoron/ dexamethasone on day 1+-dexamethasone on day2/3 in high emetogenic chemotherapy
Title of the study (Brief title)	DEX-1
Region	Japan

Condition
Condition	Malignancy
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine Pneumology Hematology and clinical oncology Gastrointestinal surgery Hepato-biliary-pancreatic surgery Chest surgery Breast surgery Obsterics and gynecology Oto-rhino-laryngology Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify that noninferiority of NK1 receptor antagonist/palonosetron/dexamethasone on day1 to NK1 receptor antagonist/palonosetron/dexamethasone on day1 to 3 in preventing acute chemotherapy-induced emesis for highly emetogenic chemotherapy regimens.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase III

Assessment
Primary outcomes	Percentage of patients with complete response (no vomiting and no rescue medication use) during the 120 hours observation period after the infusion of chemotherapy.
Key secondary outcomes	(1) Complete response rate during acute phase (0-24hr) and delayed phase (24-120hr). (2) Severity of nausea on/using Likert scale from day1 to 5 study period. (3) Adverse events related to steroid administrarion. (4) Quality of life score using EORCT QLQ-C30 on the day before chemotherapy administration and overall five days study period. (5) Adverse events defined as grade3 or higher/more on CTCAE ver 4.0

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	NK1 receptor antagonist+palonosetoron+dexamethasone day 1-3
Interventions/Control_2	NK1 receptor antagonist+palonosetoron+dexamethasone day 1
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	Male and Female
Key inclusion criteria	(1) Patients receiving highly emetogenic chemotherapy (cisplatin>=50mg/m2 or combination of anthracycline and cyclophosphamide) only day1 (2) Patients receiving highly emetogenic chemotherapy for malignant disease (3) Patients >=20 years old who can be obtained informed consent. (4) G0 of nausea and vomiting by CTCAE ver4.0 within 24 houres before entry (5) Eastern Cooperative Oncology Group(ECOG)performance status(PS) of 0 or 1 (6) Adequate organ function defined as;(each of following values are examined within 2 weeks prior to entry) ALT 100<=IU/L AST 100<=IU/L T-Bil 2.0<=mg/dL Cr 1.5<=mg/dL (7) Patient with more than three months of life expectancy. (8) All subjects must be provided written informed consent prior to entry (including QOL questionnaire).
Key exclusion criteria	(1) Hematopoietic malignancy (2) Known brain metastasis (3) Patients who cannot use cortico steroid (4) Patients taking systemic corticosteroid (topical and inhaled steroid are allowed). (5) Patients with a history of administration of highly emetogenic chemotherapy (6) Patients scheduled to receive moderately to highly emetogenic chemotherapy six days before and six after the day of highly emetogenic agent administration. (Minimally to low emetogenic agents are allowed). (7) Patients with history of or scheduled to receive radiation therapy to abdomen (below diagphram) or to pelvis from six days before chemotherapy to six days after chemotherapy. (8) Patient taking antiemetics other than study drug. (9) Patients who had a hypersensitivity reaction to NK1 receptor antagonist or palonosetoron or dexamethasone (10) Patients who are intolerant to chemotherapy (11) Pregnant, breastfeeding or expecting woman (12) Patients with uncontrolled diabetes (13) HBs are positive (14) Patients with active infection (15) Patients who are inappropriate to enter this study with any safety reasons, judged by the treating physician
Target sample size	400

Research contact person
Name of lead principal investigator	Takako Nakajima
Organization	St.Marianna University School
Division name	Clinical oncology
Address	2-16-1 Sugao Miyamae-ku Kawasaki-shi,Kanagawa,216-8511,Japan
TEL	044-977-8111
Email	n.boku@marianna-u.ac.jp

Public contact
Name of contact person	Yuka Ito
Organization	St.Marianna University School of Medicine Hospital
Division name	Department of Pharmacy
Address	2-16-1 Sugao Miyamae-ku Kawasaki-shi,Kanagawa,216-8511,Japan
TEL	044-977-8111
Homepage URL
Email	koganzai@marianna-u.ac.jp

Sponsor
Institute	St.Marianna University School of Medicine Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Graduate School of Medicine,Yokohama City University Department of Biostatistics and Epidemiology Center for Advanced Medicine and Clinical Research, Nagoya University Graduate School of Medicine
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	2012 Year 11 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2012 Year 09 Month 12 Day
Anticipated trial start date	2012 Year 10 Month 01 Day
Last follow-up date	2016 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2012 Year 09 Month 06 Day
Last modified on	2017 Year 09 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010408