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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021593
Receipt No. R000024901
Scientific Title Exploratory study for prevention of nausea and vomiting switching from Granisetron + Dexamethasone (Day1-3) + Aprepitant (Day1-3) to Palonosetron + Dexamethasone (Day1) in patients given moderately emetogenic chemotherapy
Date of disclosure of the study information 2016/03/24
Last modified on 2016/03/24

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Basic information
Public title Exploratory study for prevention of nausea and vomiting switching from Granisetron + Dexamethasone (Day1-3) + Aprepitant (Day1-3) to Palonosetron + Dexamethasone (Day1) in patients given moderately emetogenic chemotherapy
Acronym Study for switching from GRA+DEX+APR to PALO+DEX
Scientific Title Exploratory study for prevention of nausea and vomiting switching from Granisetron + Dexamethasone (Day1-3) + Aprepitant (Day1-3) to Palonosetron + Dexamethasone (Day1) in patients given moderately emetogenic chemotherapy
Scientific Title:Acronym Study for switching from GRA+DEX+APR to PALO+DEX
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate prevention of nausea and vomiting switching from Granisetron + Dexamethasone (Day1-3) + Aprepitant (Day1-3) to Palonosetron + Dexamethasone (Day1) in patients given L-OHP or CPT-11 containing chemotherapy, which correspond to the moderately emetogenic risk.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Nausea (Overall study period)
Key secondary outcomes Nausea (acute phase, delayed phase)
Complete Response (Overall study period, acute phase, delayed phase)
Complete Protection (Overall study period, acute phase, delayed phase)
Total Control (Overall study period, acute phase, delayed phase)
Evaluation method about nausea
Safety
Adverse event related to DEX

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 GRA+DEX (Day1-3)+APR(Day1-3)
PALO+DEX(Day1)
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
85 years-old >=
Gender Male and Female
Key inclusion criteria 1) Age of 20 years or older
2) Histologically confirmed colorectal cancer
3) Chemotherapy including oxaliplatin or irinotecan is planned.
4) Chemotherapy 2 courses or more by the same regimen is expected
5) Adequate function of important organs
WBC >= 3000/mm3
AST < 100 IU/L
ALT < 100 IU/L
Ccr >= 60.0mL/min
6) Eastern Cooperative Oncology Group performance status (PS) 0-2
7) Written informed concent
Key exclusion criteria 1) Serious or uncontrolled complication (e.g. ileus or pulmonary fibrosis, diabetes, heart failure, myocardial infarction, angina, kidney failure, liver failure, mental disorder, cerebrovascular disease, active gastroduodenal ulcer)
2) Symptomatic or clinically suspected brain metastasis
3) Convulsive disorder needs anticonvulsants
4) Ascites fluid or pleural effusion needs paracentesis
5) Pyloristenosis or intestinal obstruction
6) Evident anticipatory nausea and vomiting
7) Hypersensitivity for components of 5-HT3 receptor antagonist, NK1 receptor antagonist, dexamethasone
8) Pregnancy, lactation or who does not wish to contraception
9) Capability or intention of cooperating
10) Undesirable for the patient to enter the trial
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshimoto Kimura
Organization Iwate Medical University, School of Medicine
Division name Department of Surgery
Zip code
Address Uchimaru 19-1, Morioka, Japan
TEL 019-651-5111
Email toshikim@iwate-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshimoto Kimura
Organization Iwate Medical University, School of Medicine
Division name Department of Surgery
Zip code
Address Uchimaru 19-1, Morioka, Japan
TEL 019-651-5111
Homepage URL
Email toshikim@iwate-med.ac.jp

Sponsor
Institute Iwate Medical University, School of Medicine
Institute
Department

Funding Source
Organization non
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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
2016 Year 03 Month 24 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Open public recruiting
Date of protocol fixation
2016 Year 03 Month 20 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 03 Month 24 Day
Last modified on
2016 Year 03 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024901

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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