UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004501 |
|---|---|
| Receipt number | 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 20:56:35 |
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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
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
Public contact
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
Sponsor or person
Institute
Gunma Hematological Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005377
