UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007283 |
|---|---|
| Receipt number | R000008513 |
| Scientific Title | The randomized controlled trial of the R-THP-COP therapy (14 days) versus R-CHOP therapy (14 days) for treatment of patients under the age of 70 with untreated advanced stage diffuse large B-cell lymphoma, Phase II and III study |
| Date of disclosure of the study information | 2012/02/13 |
| Last modified on | 2014/11/19 19:29:51 |
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Basic information
Public title
The randomized controlled trial of the R-THP-COP therapy (14 days) versus R-CHOP therapy (14 days) for treatment of patients under the age of 70 with untreated advanced stage diffuse large B-cell lymphoma, Phase II and III study
Acronym
The randomized controlled trial of the R-THP-COP therapy (14 days) versus R-CHOP therapy (14 days) for treatment of patients under the age of 70 with untreated advanced stage diffuse large B-cell lymphoma, Phase II and III study
Scientific Title
The randomized controlled trial of the R-THP-COP therapy (14 days) versus R-CHOP therapy (14 days) for treatment of patients under the age of 70 with untreated advanced stage diffuse large B-cell lymphoma, Phase II and III study
Scientific Title:Acronym
The randomized controlled trial of the R-THP-COP therapy (14 days) versus R-CHOP therapy (14 days) for treatment of patients under the age of 70 with untreated advanced stage diffuse large B-cell lymphoma, Phase II and III study
Region
| Japan |
Condition
Condition
diffuse large B-cell lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of R-THP-COP therapy (14 days) in comparison to R-CHOP therapy (14 days) for the treatment of patients under the age of 70 with advanced stage untreated diffuse large B-cell lymphoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
Remission rate
Key secondary outcomes
response rate, survival time, safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
R-THP-COP therapy (14 days)
Interventions/Control_2
R-CHOP therapy (14 days)
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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patients who have been aounced as non-Hodgkin lymphoma.
2)Patients with histologically confirmed diffuse large B-Cell lymphomas (WHO classification 2008)
3)Patients with CD20-positive non-Hodgkin lymphoma on immunohistochemistry or flowcytometry.
4)Ann Arbor Stage:II, III, IV
5)Patients must have measurable disease.
6)Patients who were not previously treated.
7)Patients aged from 18 to 70 years old
8)ECOG performance status 0-3
9)Life expectancy greater than 4 months.
10)Patients must have normal marrow and organ function as defined below
10-1) Bone marrow function
Absolute neutrophil count >= 1000/mm3
Platelet count >= 50,000/mm3
Hemoglobin >= 8.0 g/dL
10-2) Liver funciton
AST, ALT <= 2.5 x ULN
ALP <= 2.5 x ULN
Total bilirubin <= 1.5 x ULN
10-3) Renal function
Serum creatinine <= 2.0 x ULN
10-4) Cardiac function
Normal electrocardiogram and cardiac function (without severe heart failure or cardiac arrhythmia)
11)Patients who give a written informed consent.
Key exclusion criteria
1)Patients with HIV or HTLV-1.
2)Patients with uncontrolled intercurrent illness including, but not limited to, malignant hypertension, congestive heart failure, coronary insufficiency, a new onset of myocardial infarction within 3 months , liver cirrhosis, uncontrolled hyperglycemia, renal failure, pulmonary fibrosis, or bleeding tendency.
3)Patients with another active malignancy
4)Patients who are pregnant or lactating, or have an intention to get pregnant
5)Patients with severe mental disease.
6)Patients who have had chemotherapy or radiotherapy prior to entering the study.
7)Patients who are judged inappropriate for the entry into the study by the principle doctor.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisashi Tsurumi |
Organization
Gifu University Hospital
Division name
First Department of Internal Medicine
Zip code
Address
1-1 Yanagido Gifu
TEL
058-230-6000
htsuru@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisashi Tsurumi |
Organization
Gifu University Hospital
Division name
First Department of Internal Medicine
Zip code
Address
1-1 Yanagido Gifu
TEL
058-230-6000
Homepage URL
htsuru@gifu-u.ac.jp
Sponsor or person
Institute
Gifu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Gifu University Hospital First Department of Internal Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
岐阜大学医学部附属病院（岐阜県）
木曽川市民病院（愛知県）
岐阜市民病院（岐阜県）
岐阜赤十字病院（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 13 | Day |
Related information
URL releasing protocol
http://image01.seesaawiki.jp/g/g/ghsg/9711a6b9b2a7fdb3.pdf
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
Main results already published
Date of protocol fixation
| 2006 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 13 | Day |
Last modified on
| 2014 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008513
