UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A comprehensive surveillance study on the patients with malignant lymphoma undergoing CODOX-M/IVAC regimen with or without rituximab.
Title of the study (Brief title)	A comprehensive surveillance study on the patients with malignant lymphoma undergoing CODOX-M/IVAC regimen with or without rituximab.
Region	Japan

Condition
Condition	Malignant lymphoma
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This study is aimed at evaluating the social life including quality of life and fertility after CODOX-M/IVAC with or without rituximab among the patients with newly diagnosed malignant lymphoma, focusing on subtypes with a predilection for Adolescent and Young Adult (AYA). Additionally, we clarify the efficacy of CODOX-M/IVAC regimen with or without rituximab from the aspect of long-term outcome.
Basic objectives2	Others
Basic objectives -Others	Evaluation of fertility and QOL
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Evaluation of fertility
Key secondary outcomes	Pregnancy among the patients with fertility preservation, Quality of life (SF-36), Social rehabilitation, Complications, Long-term prognostic analysis

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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Histological diagnosis of Burkitt lymphoma, Burkitt-like lymphoma in the REAL classification and B-cell lymphoma unclassifiable with features between diffuse large B-cell lymphoma and Burkitt lymphoma in the 2008 WHO lymphoma classification, and primary mediastinal large B-cell lymphoma. 2) Patients treated with CODOX-M/IVAC with or without rituximab as a first-line therapy between 2003 and 2015. 3) In the case of questionnaire investigation, 20 years of age and older in being at commencement of the study.
Key exclusion criteria	1) Patients who have a communication problem in Japanese. 2) Patients who are disqualified by their attending physician. 3) In the case of questionnaire investigation, patients undergoing second-line therapy except for additional radiation therapy for residual lesion after CODOX-M/IVAC with or without rituximab.
Target sample size	70

Research contact person
Name of lead principal investigator	Dai Maruyama
Organization	National Cancer Center Hospital
Division name	Department of Hematology
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
TEL	+81-3-3542-2511
Email	dmaruyam@ncc.go.jp

Public contact
Name of contact person	Kosuke Toyoda
Organization	National Cancer Center Hospital
Division name	Department of Hematology
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
TEL	+81-3-3542-2511
Homepage URL
Email	ktoyoda@ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital
Institute
Department

Funding Source
Organization	National Cancer Center Research and Development Fund
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 11 Month 15 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 11 Month 15 Day
Anticipated trial start date	2016 Year 11 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	1) Social life, including evaluation of fertility and social rehabilitation 2) Assessment of QOL, using SF-36 3) Complication after CODOX-M/IVAC with or without rituximab 4) Clinical information, containing prognosis

Management information
Registered date	2016 Year 11 Month 15 Day
Last modified on	2016 Year 11 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028587