UMIN-CTR Clinical Trial

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
Email	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
Email	kubota-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	Gifu University ethics committee
Address	Yanagido1-1, Gifu
Tel	058-230-6059
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028370