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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN C000000036
Receipt No. R000000077
Scientific Title Randomized phase III study of Standard CHOP(S-CHOP) versus Biweekly CHOP(Bi-CHOP) in aggressive Non-Hodgkin's Lymphoma(JCOG9809)
Date of disclosure of the study information 2005/08/04
Last modified on 2014/03/05

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Basic information
Public title Randomized phase III study of Standard CHOP(S-CHOP) versus Biweekly CHOP(Bi-CHOP) in aggressive Non-Hodgkin's Lymphoma(JCOG9809)
Acronym Randomized phase III study of Standard CHOP(S-CHOP) versus Biweekly CHOP(Bi-CHOP) in aggressive Non-Hodgkin's Lymphoma(JCOG9809)
Scientific Title Randomized phase III study of Standard CHOP(S-CHOP) versus Biweekly CHOP(Bi-CHOP) in aggressive Non-Hodgkin's Lymphoma(JCOG9809)
Scientific Title:Acronym Randomized phase III study of Standard CHOP(S-CHOP) versus Biweekly CHOP(Bi-CHOP) in aggressive Non-Hodgkin's Lymphoma(JCOG9809)
Region
Japan

Condition
Condition Non-Hodgkin's lymphoma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 o investigate clinical benefit of dose intensified regimen, Bi-CHOP incomparison standard CHOP for advanced intermediate or high grade NHL.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Progression free survival
Key secondary outcomes overall survival, complete remission rate, toxicity

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Chemotherapy:Standard CHOP
Interventions/Control_2 Chemotherapy:Bi-CHOP(dose intensified CHOP)
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
69 years-old >=
Gender Male and Female
Key inclusion criteria (1)Intermediate- or high-grade non-Hodgkin's lymphoma, excluding CTCL, ATL and T-LbL (Working Formulation)
(2)Ann Arbor stage: II, III, IV
(3)No prior chemotherapy or radiotherapy
(4)Age: 15 to 69
(5)PS: 0, 1, 2
(6)WBC >= 3,000 /mm3, ANC >= 1,200 /mm3, Platelet >= 75,000 /mm3
(7)GOT/GPT <= 5 x Normal Upper Limit, T-Bil <= 2.0 mg/dL
(8)Creatinine <= 2.0 mg/dL
(9)normal ECG, Ejection Fraction >= 50%
(10)PaO2 >= 65 mmHg
(11)Written informed consent
Key exclusion criteria (1)uncontrolable diabetes mellitus
(2)severe complication (infection, heart failure, renal failure, liver failure, etc)
(3)anamnesis of heart disease
(4)acute or chronic hepatitis, liver chirrosis and portal hypertension
(5)synchronous or metachronous malignancy
(6)sever plumonary dysfunction
(7)CNS invasion
(8)HIV positive
(9)HBs-Ag positive
(10)HCV-Ab positive
Target sample size 450

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomomitsu Hotta, MD, PhD
Organization Tokai university
Division name Department of Medicine, Hematology/Oncology
Zip code
Address 143 Simolasuya, Isehara, Kanagawa, 259-1193, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Ken Ohmachi, MD
Organization JCOG9809 Coordinating Office
Division name Department of Medicine, Hematology/Oncology, Tokai university
Zip code
Address 143 Simolasuya, Isehara, Kanagawa, 259-1193, 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 YES
Study ID_1 NCT00133302
Org. issuing International ID_1 ClinicalTrials.gov by NLM
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 04 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/21196441
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 Terminated
Date of protocol fixation
1998 Year 09 Month 24 Day
Date of IRB
Anticipated trial start date
1999 Year 02 Month 01 Day
Last follow-up date
2005 Year 02 Month 01 Day
Date of closure to data entry
2005 Year 02 Month 01 Day
Date trial data considered complete
2005 Year 02 Month 01 Day
Date analysis concluded
2005 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 08 Month 04 Day
Last modified on
2014 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000077

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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