UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000036 |
|---|---|
| Receipt number | 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 16:09:08 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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/
JCOG_sir@ml.jcog.jp
Sponsor or person
Institute
Japan Clinical Oncology Group(JCOG)
Institute
Department
Personal name
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
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
Value
https://center6.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 |
