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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007282
Receipt No. R000008319
Scientific Title The randomized controlled trial of the R-THP-COP therapy versus R-CHOP therapy for treatment of elderly patients 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 2014/02/14

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Basic information
Public title The randomized controlled trial of the R-THP-COP therapy versus R-CHOP therapy for treatment of elderly patients 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 versus R-CHOP therapy for treatment of elderly patients 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 versus R-CHOP therapy for treatment of elderly patients 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 versus R-CHOP therapy for treatment of elderly patients 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 in comparison to R-CHOP therapy for the treatment of patients aged 60 years or older 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
Interventions/Control_2 R-CHOP therapy
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
60 years-old <=
Age-upper limit

Not applicable
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 over 60 years.
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 70

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
Email 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
Email htsuru@gifu-u.ac.jp

Sponsor
Institute Gifu University Hospital
Institute
Department

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
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 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
Publication of results Unpublished

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 No longer recruiting
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 02 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008319

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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