UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II clinical trial of multidisciplinary therapy using risk classification based on residual tumor volume and WHO grading for pediatric ependymoma patients (JCCG EPN1501)
Title of the study (Brief title)	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	Hara Junichi
Organization	Osaka City Hospital Organization, Osaka City General Hospital
Division name	Pediatric Hematology & Oncology
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	Yamamoto Tetsuya
Organization	University of Tsukuba, Faculty of Medicine
Division name	Neurosurgery
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 07 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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