Unique ID issued by UMIN | C000000053 |
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Receipt number | R000000098 |
Scientific Title | CHOP therapy for low and low-intermediate risk patients of advanced aggressive non-Hodgkin's lymphoma (JCOG9508, LSG17(CHOP)) |
Date of disclosure of the study information | 2005/08/09 |
Last modified on | 2014/02/21 13:52:43 |
CHOP therapy for low and low-intermediate risk patients of advanced aggressive non-Hodgkin's lymphoma (JCOG9508, LSG17(CHOP))
CHOP therapy for low and low-intermediate risk patients of advanced aggressive non-Hodgkin's lymphoma (JCOG9508, LSG17(CHOP))
CHOP therapy for low and low-intermediate risk patients of advanced aggressive non-Hodgkin's lymphoma (JCOG9508, LSG17(CHOP))
CHOP therapy for low and low-intermediate risk patients of advanced aggressive non-Hodgkin's lymphoma (JCOG9508, LSG17(CHOP))
Japan |
low and low-intermediate risk of aggressive non-Hodgkin's lymphoma
Hematology and clinical oncology |
Malignancy
NO
To evaluate the survival rate of CHOP hterapy for low and low-intermediate risk of aggressive non-Hodgkin's lymphoma
Efficacy
Exploratory
Phase II
overall survival
Complete remission rate, Progression free survaval, adverse reaction/adverse effect
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Chemotherapy (8 courses of CHOP)
15 | years-old | <= |
70 | years-old | > |
Male and Female
(1) histologically diagnosed non-Hodgkin's lymphoma with intermediate or high grade by Working Formulation, except for transformation from low grade lymphoma, ATL, T-lymphoblastic lymphoma, mycosis fungoideus, and Sezary syndrome.
(2) Clinical stage of I-bulky, II, III, IV by Ann Arbor classification.
(3) No previous chemotherapy or radiotherapy.
(4) Age: between 15 and 69.
(5) Performance Status: between 0 and 3.
(6) Low or low-intermediate risk by International index
(7) No organ dysfuction; neutrophil count>1200/ml, platelet count >75000/ml, ASTand ALT level <5 times the upper limit of the normal range, total bilirubin level < 2.0 mg/dl, serum creatinin level < 2.0mg/dl, no cardiac dysfunction.
(8) Understanding and agreement of written informed consent.
1) Complication; severe infection, heart failure, respiratory failure, hepatic failure, organic pulumonary disease, liver cirrhosis, acute or chronic hepatitis, renal failure.
2) Active or non-curable synchronous malignancy, except for cervical carcinoma in situ or basal carcinoma of the skin.
3) Psycological disorder like schizophrenia.
4) Heart disease which is deteriorated by anthracyclins, past history of myocardial infarction, or angina pectoris during 3 months before registration.
5) Pregnant or nursing .
6) Involvement of central nervous system
7) HIV infection
160
1st name | |
Middle name | |
Last name | Michinori Ogura, MD, PhD |
Nagoya Daini Red-cross Hospital
Department of Hematology
2-9 myouken-cho, Shouwa-ku, Nagoya, JAPAN
1st name | |
Middle name | |
Last name | Yoshitoyo Kagami, MD, PhD |
JCOG9508 Coordinating Office
Department of Hematology and Cell-therapy, Aichi Cancer Center Hospital
1-1 Kanokoden, Chikusa-ku, Nagoya, 464-8681, JAPAN
http://www.jcog.jp/
JCOG_sir@ml.jcog.jp
Japan Clinical Oncology Group(JCOG)
Ministry of Health, Labour and Welfare
Japan
NO
2005 | Year | 08 | Month | 09 | Day |
Published
http://www.ncbi.nlm.nih.gov/pubmed/22661011
See the datails via "URL releasing results" above.
Also the details can be seen in the JCOG website:
http://www.jcog.jp/en/trials/index.html
Completed
1995 | Year | 04 | Month | 19 | Day |
1995 | Year | 06 | Month | 01 | Day |
2004 | Year | 07 | Month | 01 | Day |
2004 | Year | 08 | Month | 01 | Day |
2004 | Year | 08 | Month | 01 | Day |
2005 | Year | 01 | Month | 01 | Day |
2005 | Year | 08 | Month | 09 | Day |
2014 | Year | 02 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000098
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