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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000008867
Receipt No. R000010408
Scientific Title Placebo-controlled,double-blind,randomized study of comparing NK1 receptor antagonist/ palonosetoron/ dexamethasone on day 1+-dexamethasone on day2/3 in high emetogenic chemotherapy
Date of disclosure of the study information 2012/11/01
Last modified on 2017/09/11

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Basic information
Public title Placebo-controlled,double-blind,randomized study of comparing NK1 receptor antagonist/ palonosetoron/ dexamethasone on day 1+-dexamethasone on day2/3 in high emetogenic chemotherapy
Acronym DEX-1
Scientific Title Placebo-controlled,double-blind,randomized study of comparing NK1 receptor antagonist/ palonosetoron/ dexamethasone on day 1+-dexamethasone on day2/3 in high emetogenic chemotherapy
Scientific Title:Acronym 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
1st name
Middle name
Last name Takako Nakajima
Organization St.Marianna University School
Division name Clinical oncology
Zip code
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
1st name
Middle name
Last name Yuka Ito
Organization St.Marianna University School of Medicine Hospital
Division name Department of Pharmacy
Zip code
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)

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
2012 Year 11 Month 01 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 Main results already published
Date of protocol fixation
2012 Year 09 Month 12 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000010408

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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