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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004501
Receipt No. R000005377
Scientific Title CPT-11, Carbopplatin, Dexamethasone commbination chemotherapy for refractory aggressive lymphoma
Date of disclosure of the study information 2010/11/03
Last modified on 2013/06/25

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Basic information
Public title CPT-11, Carbopplatin, Dexamethasone commbination chemotherapy for refractory aggressive lymphoma
Acronym CPT, CBDCA, Dex for aggresive lymphoma
Scientific Title CPT-11, Carbopplatin, Dexamethasone commbination chemotherapy for refractory aggressive lymphoma
Scientific Title:Acronym CPT, CBDCA, Dex for aggresive lymphoma
Region
Japan

Condition
Condition refactory aggressive lymphoma
Classification by specialty
Medicine in general Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 effectiveness of combination chemotherapy consist of CPT-11, carboplatin, and dexamethasone
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes response rate
Key secondary outcomes adverse event

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
18 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria 1. refractory for first line chemotherapy
2. age between 18 and 70
3. PS 0-2
4. expected to be alive for 3 months
5. normal of hematopoiesis and liver and renal function tests
Key exclusion criteria 1. anaphylasis foo\r carboplatin
2. diarrhea
3. ileus
4. peptic ulcer
5. interstitial pneumonitis
Target sample size 35

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Norifumi Tsukamoto
Organization Gunma University graduate school
Division name Medicine and clinical science
Zip code
Address 3-39-15 showa-machi Maebashi, Gunma
TEL 027-220-8166
Email

Public contact
1st name of contact person
1st name
Middle name
Last name Norifumi Tsukamoto
Organization Gunma University graduate school
Division name Medicine and Clinicla Science
Zip code
Address 3-39-15 showa-machi Maebashi, Gunma
TEL 027-220-8166
Homepage URL
Email

Sponsor
Institute Gunma Hematological Study Group
Institute
Department

Funding Source
Organization Medicine and Clinical Science
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 西群馬病院、藤岡総合病院、群馬県立がんセンター、

Other administrative information
Date of disclosure of the study information
2010 Year 11 Month 03 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 Open public recruiting
Date of protocol fixation
2010 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 11 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 effectiveness and grade of adverse event

Management information
Registered date
2010 Year 11 Month 03 Day
Last modified on
2013 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005377

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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