UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026100 |
|---|---|
| Receipt number | R000028370 |
| Scientific Title | Study of efficacy and safety of reduced chemotherapy and risk evaluation of perforation by Endoscopy for gastrointestinal non-Hodgkin Lymphoma |
| Date of disclosure of the study information | 2017/02/12 |
| Last modified on | 2020/08/19 08:15:57 |
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Basic information
Public title
Study of efficacy and safety of reduced chemotherapy and risk evaluation of perforation by Endoscopy for gastrointestinal non-Hodgkin Lymphoma
Acronym
Study of efficacy and safety of reduced chemotherapy and risk evaluation of perforation by Endoscopy for gastrointestinal non-Hodgkin Lymphoma
Scientific Title
Study of efficacy and safety of reduced chemotherapy and risk evaluation of perforation by Endoscopy for gastrointestinal non-Hodgkin Lymphoma
Scientific Title:Acronym
Study of efficacy and safety of reduced chemotherapy and risk evaluation of perforation by Endoscopy for gastrointestinal non-Hodgkin Lymphoma
Region
| Japan |
Condition
Condition
Gastrointestinal non-Hodgkin lymphoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of reduced chemotherapy and risk evaluation of perforation by Endoscopy for gastrointestinal non-Hodgkin Lymphoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Success of the treatment rate
Key secondary outcomes
Overall response rate
Complete response rate
Overall survival
Progression-free survival
Safety
Validity of evaluation of perforation by EUS
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Cyclophosphamide 525mg/m2 DIV Day1
Adriamycin or Therarubicin 35mg/m2 DIV Day1
Vincristine 1mg/m2(max 2mg)DIV Day1
Prednisolone Oral 100mg/body Day1-5
Rituximab DIV 375mg/m2 Day0
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Newly non-Hodgkin lymphoma pts confirmed with histology.
2) It is possible to evaluate the digestive tract lesions (esophagus, stomach, duodenum, ileum, jejunum, colon) by endoscopy.3) Aged 18 or older.
4. ECOG performance status 0-2
5. Patients meet all following standard
Absolute neutrophil count >= 1,000/mm3, Hemoglobin >= 8.0 g/dL, Platelet count >= 75,000/mm3, AST and ALT < 2.5 times facility criteria, Total bilirubin < 2.5 times facility criteria, Creatinine Clearance >= 30ml/min.
6.Written informed consent obtained.
Key exclusion criteria
1) CNS involvement
2) Serologically positive for HIVAb
3) Perforation or penetration of the digestive tract before treatment
4) Severe infection or clinical complication
5) Pregnant, possible pregnant, or breastfeeding woman
6) Active malignancy concomitantly existed
7) Known allergy for study drugs
8) Known resistance for study drugs
9) Patients who have been judged by the investigator to be inappropriate for participation in this clinical trial for other reasons.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masaya |
| Middle name | |
| Last name | Kubota |
Organization
Gifu University
Division name
Department of Hematology
Zip code
501-1194
Address
Yanagido1-1, Gifu
TEL
058-230-6308
kubota-gif@umin.ac.jp
Public contact
Name of contact person
| 1st name | Masaya |
| Middle name | |
| Last name | Kubota |
Organization
Gifu University
Division name
Department of Hematology
Zip code
501-1194
Address
Yanagido1-1, Gifu
TEL
058-230-6308
Homepage URL
kubota-gif@umin.ac.jp
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
Funding Source
Organization
Gifu University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gifu University ethics committee
Address
Yanagido1-1, Gifu
Tel
058-230-6059
gjme00004@jim.gifu-u.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 12 | 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
| 2016 | Year | 09 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 07 | 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
| 2017 | Year | 02 | Month | 11 | Day |
Last modified on
| 2020 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028370
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| Registered date | File name |
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