UMIN-CTR Clinical Trial

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

Pediatric ependymoma

Classification by specialty

Hematology and clinical oncology	Pediatrics	Radiology
Neurosurgery

Classification by malignancy

Malignancy

Genomic information

YES

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

The Japan Children's Cancer Group(JCCG)

Institute

Department

Personal name

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

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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))　　

Date of disclosure of the study information

2016

Year

10

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

08

Month

29

Day

Last modified on

2016

Year

08

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027426