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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023803
Receipt No. R000027426
Scientific Title Phase II clinical trial of multidisciplinary therapy using risk classification based on residual tumor volume and WHO grading for pediatric ependymoma patients (JCCG EPN1501)
Date of disclosure of the study information 2016/10/20
Last modified on 2016/08/29

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Basic information
Public title Phase II clinical trial of multidisciplinary therapy using risk classification based on residual tumor volume and WHO grading for pediatric ependymoma patients (JCCG EPN1501)
Acronym Phase II clinical trial of multidisciplinary therapy for pediatric ependymoma patients( JCCG EPN1501)
Scientific Title Phase II clinical trial of multidisciplinary therapy using risk classification based on residual tumor volume and WHO grading for pediatric ependymoma patients (JCCG EPN1501)
Scientific Title:Acronym Phase II clinical trial of multidisciplinary therapy for pediatric ependymoma patients( JCCG EPN1501)
Region
Japan

Condition
Condition Pediatric ependymoma
Classification by specialty
Hematology and clinical oncology Pediatrics Radiology
Neurosurgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The purpose of this phase II clinical trial is to evaluate feasibility and effectiveness of multidisciplinary therapy for the patients with newly diagnosed intracranial ependymoma_aged not less than 3 years-old and under 20 years-old. The therapeutic modalities are determined by risk classification system based on tumor location, WHO grading, and extent of resection.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes 2 Year - Progression Free Survival rate
Key secondary outcomes 2 Year - Progression Free Survival rate for each Group, WHO classification

2 Year - Overall Survival rate


5 Year - Progression Free Survival rate


5 Year - Overall Survival rate


7 Year - Progression Free Survival rate


7 Year - Overall Survival rate


Re-operation rate after completion of chemotherapy

Extent of surgical removal rate

Response rate of chemotherapy

Occurrence rate of adverse events (for al
l cases, and for each Group)

Relationship between molecular diagnosis and clinical characteristics

Relationship between clinical characteristics and therapies and neuropsychological function

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Group A: The patients with gross total removal without residual tumor intraoperatively and without residual tumor on postoperative MRI(GTR1), or supratentrial tumor with WHO grade2_These patients should be observed thereafter



Group B: The patients with GTR1 and WHO grade3, The patients with GTR1 and infratentorial tumor with any location and any WHO grading, The patients with gross total removal with residual tumor intraoperatively and without residual tumor on postoperative MRI (GTR2) or with residual tumor no more than 5 mm thickness on cortical surface of brain or intracranially on postoperative MRI(NTR) with any location and any WHO grading_These patients should get 3D-conformal radiation therapy within 3 weeks after inclusion as well as 6 weeks postoperatively, and thereafter observation are needed



Group C: The patients with residual tumor no less than 5 mm thickness on cortical surface of brain or intracranially on postoperative MRI with any location and any WHO grading, Biopy cases are included in this GroupC


C-1: The patients with resectable residual tumor after completion of 2 course chemotherapy_These patients should get re-operation within 6 weeks after start of the second circle of chemotherapy_These patients should start 3D-conformal radiation therapy within 4 weeeks postoperatively and thereafter observation are needed

C-2: The patients with non-resectable residual tumor after completion of 2 course chemotherapy_These patients should get 3D-conformal radiation therapy within 6 weeks after start of the second circle of chemotherapy, and thereafter observation are needed
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
3 years-old <=
Age-upper limit
20 years-old >
Gender Male and Female
Key inclusion criteria 1) Tumor removal or biopsy performed as an initial treatment, and diagnosed ependymoma by central review for pathological diagnosis according to the protocol


2) Within 6 weeks after tumor removal or biopsy


3) No dissemination other than initial tumor location

4) Age, no less than 3 years-old and under 20 years-old when they are included to this clinical trial


5) Without any previous radiation therap
y and chemotherapy

6) ECOG Performance Status(PS) with no more than 3


7) Written informed consent on this clinical trial
For no less than 16 years-old, Informed consent with patient and his or her alternatives
For no more than 15 years-old, Informed consent with patient's alternatives
Key exclusion criteria 1)Synchronous or an asynchronous(within 5 years) other cancer

2)Existing heart disease to be treated


3)Pregnant or during breast-feeding

4)Inappropriate inclusion judged by attending physician


Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hara Junichi
Organization Osaka City Hospital Organization, Osaka City General Hospital
Division name Pediatric Hematology & Oncology
Zip code
Address 2-13-22, Toshimahondori, Toshima, Osaka, Osaka prefecture, ZIP CODE 5340021, JAPAN
TEL 06-6929-1221
Email j-hara@med.osakacity-hp.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yamamoto Tetsuya
Organization University of Tsukuba, Faculty of Medicine
Division name Neurosurgery
Zip code
Address 2-1-1, Amakubo, Tsukuba, Ibaraki prefecture,ZIP Code 3058576, JAPAN
TEL 029-853-3900
Homepage URL
Email yamamoto_neurosurg@md.tsukuba.ac.jp

Sponsor
Institute The Japan Children's Cancer Group(JCCG)
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development, Advanced Research & Development Programs for Medical Innovation
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization JAPAN

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

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 地方独立行政法人大阪市民病院機構大阪市立総合医療センター(大阪)(Osaka City Hopital Organization, Osaka City General Hospital(Osaka prefecture)), 筑波大学附属病院(茨城県)(University of Tsukuba Hospital(Ibaraki prefecture))  

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 20 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 Preinitiation
Date of protocol fixation
2016 Year 07 Month 20 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 20 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
2016 Year 08 Month 29 Day
Last modified on
2016 Year 08 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027426

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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