UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019093
Receipt number R000022077
Scientific Title Phase II study of interim FDG-PET-guided response-adapted therapy in pediatric patients with Hodgkin's lymphoma (HL-14)
Date of disclosure of the study information 2015/10/01
Last modified on 2018/05/07 08:42:51

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Basic information

Public title

Phase II study of interim FDG-PET-guided response-adapted therapy in pediatric patients with Hodgkin's lymphoma (HL-14)

Acronym

Phase II study of interim FDG-PET-guided response-adapted therapy in pediatric patients with Hodgkin's lymphoma (HL-14)

Scientific Title

Phase II study of interim FDG-PET-guided response-adapted therapy in pediatric patients with Hodgkin's lymphoma (HL-14)

Scientific Title:Acronym

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

1st name
Middle name
Last name Yuhki Koga

Organization

Graduate School of Medical Sciences Kyushu University

Division name

Department of Pediatrics

Zip code


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

1st name
Middle name
Last name Yuhki Koga

Organization

Graduate School of Medical Sciences Kyushu University

Division name

Department of Pediatrics

Zip code


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 or person

Institute

Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)

Institute

Department

Personal name



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


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

2015 Year 10 Month 01 Day


Related information

URL releasing protocol

http://jplsg.jp/index.htm

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

Enrolling by invitation

Date of protocol fixation

2015 Year 08 Month 21 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022077


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name