UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of interim FDG-PET-guided response-adapted therapy in pediatric patients with Hodgkin's lymphoma (HL-14)
Title of the study (Brief title)	Phase II study of interim FDG-PET-guided response-adapted therapy in pediatric patients with Hodgkin's lymphoma (HL-14)
Region	Japan

Condition
Condition	Hodgkin's lymphoma
Classification by specialty	Hematology and clinical oncology Pediatrics
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	In targeting cases of Hodgkin's lymphoma (HL) in children under age 20, we confirm whether we can omit radiation therapy for FDG-PET negative cases after 2 courses of multi-drug chemotherapy. By determining remission using PET examinations with both high sensitivity and high specificity, the goal is to detect the cases that truly require radiation therapy, and for other cases carry out treatment without radiation therapy, in order to maintain a high survival rate while ensuring safety.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	5-year event-free survival
Key secondary outcomes	5-year overall survival ratio of complete remission ratio of interim-PET negative ratio of acute and late side effect

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 Device,equipment
Interventions/Control_1	Omit radiation therapy for FDG-PET negative cases after 2 courses of multi-drug chemotherapy
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	0 years-old <=
Age-upper limit	20 years-old >
Gender	Male and Female
Key inclusion criteria	(1) diagnosis of Hodgkin's lymphoma (2) age under 20 year old at diagnosis (3) registration at JPLSG CHM-14 study (4) written informed consent obtained from patient or guardians.
Key exclusion criteria	(1) Cases where impaired liver, kidney and cardiac functions compromise experimental treatment (2) Patients who have been treated with anticancer drugs or radiation therapy (3) Presence of CNS degenerative lesion (4) Associated intracranial hemorrhage which hinders execution of treatment process (5) Associated infection which is difficult to control (6) Pregnant or possibility of pregnancy (7) Women who are breastfeeding (8) Past history of malignant neoplasm or multiple primary neoplasms (9) History of congenital or acquired immune deficiency syndrome (10) Any other reasons that the attending physician has deemed unsuitable
Target sample size	50

Research contact person
Name of lead principal investigator	Yuhki Koga
Organization	Graduate School of Medical Sciences Kyushu University
Division name	Department of Pediatrics
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582
TEL	092-642-5093
Email	yuuki-k@pediatr.med.kyushu-u.ac.jp

Public contact
Name of contact person	Yuhki Koga
Organization	Graduate School of Medical Sciences Kyushu University
Division name	Department of Pediatrics
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582
TEL	092-642-5093
Homepage URL	http://jplsg.jp/index.htm
Email	yuuki-k@pediatr.med.kyushu-u.ac.jp

Sponsor
Institute	Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)
Institute
Department

Funding Source
Organization	Grant for clinical cancer research from the Ministry of Health, Labour and Welfare, Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)	Grant from the National Center for Child Health and Development

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	2015 Year 10 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 08 Month 21 Day
Anticipated trial start date	2015 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol	http://jplsg.jp/index.htm
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 09 Month 23 Day
Last modified on	2018 Year 05 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022077