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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000053
Receipt No. 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

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Basic information
Public title CHOP therapy for low and low-intermediate risk patients of advanced aggressive non-Hodgkin's lymphoma (JCOG9508, LSG17(CHOP))
Acronym CHOP therapy for low and low-intermediate risk patients of advanced aggressive non-Hodgkin's lymphoma (JCOG9508, LSG17(CHOP))
Scientific Title CHOP therapy for low and low-intermediate risk patients of advanced aggressive non-Hodgkin's lymphoma (JCOG9508, LSG17(CHOP))
Scientific Title:Acronym CHOP therapy for low and low-intermediate risk patients of advanced aggressive non-Hodgkin's lymphoma (JCOG9508, LSG17(CHOP))
Region
Japan

Condition
Condition low and low-intermediate risk of aggressive non-Hodgkin's lymphoma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the survival rate of CHOP hterapy for low and low-intermediate risk of aggressive non-Hodgkin's lymphoma
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes overall survival
Key secondary outcomes Complete remission rate, Progression free survaval, adverse reaction/adverse effect

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Chemotherapy (8 courses of CHOP)
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
15 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria (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.
Key exclusion criteria 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
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michinori Ogura, MD, PhD
Organization Nagoya Daini Red-cross Hospital
Division name Department of Hematology
Zip code
Address 2-9 myouken-cho, Shouwa-ku, Nagoya, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshitoyo Kagami, MD, PhD
Organization JCOG9508 Coordinating Office
Division name Department of Hematology and Cell-therapy, Aichi Cancer Center Hospital
Zip code
Address 1-1 Kanokoden, Chikusa-ku, Nagoya, 464-8681, JAPAN
TEL
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group(JCOG)
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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
2005 Year 08 Month 09 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/22661011
Number of participants that the trial has enrolled
Results
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
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 Completed
Date of protocol fixation
1995 Year 04 Month 19 Day
Date of IRB
Anticipated trial start date
1995 Year 06 Month 01 Day
Last follow-up date
2004 Year 07 Month 01 Day
Date of closure to data entry
2004 Year 08 Month 01 Day
Date trial data considered complete
2004 Year 08 Month 01 Day
Date analysis concluded
2005 Year 01 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 08 Month 09 Day
Last modified on
2014 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000098

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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