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
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
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
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
