UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008867 |
|---|---|
| Receipt number | 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 07:10:56 |
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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 | Obstetrics 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
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
koganzai@marianna-u.ac.jp
Sponsor or person
Institute
St.Marianna University School of Medicine Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010408
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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