Unique ID issued by UMIN | UMIN000008932 |
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Receipt number | 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 09:54:54 |
A phase II study of palonosetron to prevent nausea and vomiting induced by CHOP therapy in malignant lymphoma cancer patients.
A phase II study of palonosetron to prevent nausea and vomiting induced by CHOP therapy in malignant lymphoma cancer patients.
A phase II study of palonosetron to prevent nausea and vomiting induced by CHOP therapy in malignant lymphoma cancer patients.
A phase II study of palonosetron to prevent nausea and vomiting induced by CHOP therapy in malignant lymphoma cancer patients.
Japan |
malignant lymphoma cancer.
Hematology and clinical oncology |
Malignancy
NO
To evaluate the efficacy and safety of palonosetron on CINV in malignant lymphoma cancer patients receiving CHOP therapy.
Safety,Efficacy
Exploratory
Explanatory
Phase II
Complete Response Rate in overall phase(0-120 hours after chemotherapy)
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Palonosetron:
day1 0.75mg (i.v.)
20 | years-old | <= |
Not applicable |
Male and Female
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
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
55
1st name | |
Middle name | |
Last name | Hirotoshi Kamata |
Department of Medicine Kitasato University, School of Medicine
Hematology
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0374,
0427788111
1st name | |
Middle name | |
Last name | Hirotoshi Kamata |
Department of Medicine Kitasato University, School of Medicine
Hematology
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0374, Japan
0427788111
Hematology, Department of Medicine Kitasato University, School of Medicine
none
Self funding
NO
北里大学病院(神奈川県)
2012 | Year | 09 | Month | 17 | Day |
Unpublished
Open public recruiting
2012 | Year | 07 | Month | 18 | Day |
2012 | Year | 08 | Month | 15 | Day |
2014 | Year | 08 | Month | 01 | Day |
2012 | Year | 09 | Month | 17 | Day |
2012 | Year | 09 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010471
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