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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026100
Receipt No. 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 2017/02/11

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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
Middle name
Last name Ysurumi Hisashi
Organization Gifu University
Division name Department of Hematology
Zip code
Address Yanagido1-1, Gifu
TEL 058-230-6308
Email htsuru@gifu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junichi Kitagawa
Organization Gifu University
Division name Department of Hematology
Zip code
Address Yanagido1-1, Gifu
TEL 058-230-6308
Homepage URL
Email jkita-gif@umin.ac.jp

Sponsor
Institute Gifu University
Institute
Department

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
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

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
2017 Year 02 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028370

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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