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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008932
Receipt No. R000010471
Scientific Title A phase II study of palonosetron to prevent nausea and vomiting induced by CHOP therapy in malignant lymphoma cancer patients.
Date of disclosure of the study information 2012/09/17
Last modified on 2012/09/17

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Basic information
Public title A phase II study of palonosetron to prevent nausea and vomiting induced by CHOP therapy in malignant lymphoma cancer patients.
Acronym A phase II study of palonosetron to prevent nausea and vomiting induced by CHOP therapy in malignant lymphoma cancer patients.
Scientific Title A phase II study of palonosetron to prevent nausea and vomiting induced by CHOP therapy in malignant lymphoma cancer patients.
Scientific Title:Acronym A phase II study of palonosetron to prevent nausea and vomiting induced by CHOP therapy in malignant lymphoma cancer patients.
Region
Japan

Condition
Condition malignant lymphoma cancer.
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of palonosetron on CINV in malignant lymphoma cancer patients receiving CHOP therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Complete Response Rate in overall phase(0-120 hours after chemotherapy)
Key secondary outcomes Complete Response Rate in acute and delayed phase
Complete Control Rate in overall, acute and delayed phase
The proportion of patients without nausea in overall, acute and delayed phase
Safety

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 Palonosetron:
day1 0.75mg (i.v.)
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients who receive CHOP or R-CHOP therapy for malignant lymphoma cancer patients
2)No prior chemotherapy
3) Aged 20 years or older
4) Adequate organ function
5) ECOG performance status of 0 or 2
6) Written informed consent
Key exclusion criteria 1) With other sever diseases
2) Clinical suspicion or history of metastasis to brain or meninges
3) Patients who need anticonvulsants therapy
4) Ascites and/or pleural effusion to need treatment
5) Pyloric stenosis and/or intestinal obstruction
6) Vomiting, or grade 2 or higher nausea according to CTCAE ver4.0
7) History of drug allergy
8) Pregnant or lactating women or women of childbearing potential, and no birth-control
9) Patient who doesn't have ability or intention that cooperates for procedure of the study
10) Not appropriate for the study at the physician's assessment
Target sample size 55

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirotoshi Kamata
Organization Department of Medicine Kitasato University, School of Medicine
Division name Hematology
Zip code
Address 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0374,
TEL 0427788111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hirotoshi Kamata
Organization Department of Medicine Kitasato University, School of Medicine
Division name Hematology
Zip code
Address 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0374, Japan
TEL 0427788111
Homepage URL
Email

Sponsor
Institute Hematology, Department of Medicine Kitasato University, School of Medicine
Institute
Department

Funding Source
Organization none
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 北里大学病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2012 Year 09 Month 17 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
2012 Year 07 Month 18 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 15 Day
Last follow-up date
2014 Year 08 Month 01 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 17 Day
Last modified on
2012 Year 09 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010471

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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