UMIN-CTR Clinical Trial

Public title

A Phase 2 Trial of Multimodal Treatment based on VDC-IE with Interval Compressed Schedule by using G-CSF for Patients with Non-metastatic Ewing Sarcoma Family Tumor

Acronym

Interval Compressed VDC-IE for Non-metastatic ESFT (JESS14)

Scientific Title

A Phase 2 Trial of Multimodal Treatment based on VDC-IE with Interval Compressed Schedule by using G-CSF for Patients with Non-metastatic Ewing Sarcoma Family Tumor

Scientific Title:Acronym

Interval Compressed VDC-IE for Non-metastatic ESFT (JESS14)

Region

Japan

Condition

Non-metastatic Ewing Sarcoma Family Tumor

Classification by specialty

Hematology and clinical oncology	Surgery in general	Pediatrics
Orthopedics	Radiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate an efficacy and safety of interval compression schedule with VDC-IE chemotherapy (bi-weekly VDC-IE) supported by granulocyte colony stimulating factor (G-CSF) for patients with newly diagnosed localized Ewing Sarcoma Family Tumor (ESFT) in phase 2 clinical trial

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

3-year progression free survival

Key secondary outcomes

3-year overall survival.
Completion rate of induction chemotherapy.
Rate of the patients who complete 6 cycles of VDC-IE therapy with G-CSF support within 14 weeks.
Duration(days) in every chemotherapy cycle.
Response rate of induction chemotherapy.
Profile of adverse event.
Histologic response rate.
Completion rate of 14 course of chemotherapy.
Dose of every chemotherapeutic agent.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Chemotherapy
1)VDC therapy
2)IE therapy
3)VC therapy
Surgery
Radiotherapy

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

Not applicable

Age-upper limit

50

years-old

>

Gender

Male and Female

Key inclusion criteria

1)Histologically comfirmed newly diagnosed ESFT.
2)Localized tumor.
3)Within 3 weeks after histologically diagnosis.
4)No history of prior chemotherapy or radiation therapy.
5)Age younger than 50 years old.
6)Patients must have sufficient organ function satisfying the labolatory data listed below.
1.PS: Karnovsky score 50% or higher
2.WBC 2000/micro L or higher
PLT 100000/micro L or higher
3.GPT within 2 times upper limit of
institution
4.Serum creatinine level
0.8mg/dl or lower for the patients
younger than 5 years old
1.2mg/dl or lower for the patients
5 to 10 years old
1.5mg/dl or lower for the patients
older than 5 years old
5.Normal electrolytes level
6.No heart disease which require any
treatment
7)All patients and/or their parents or legal guardians must sign a written informed consent.
8)Remain evaluable lesion.(Not complete resection)
9)Completion of primary registration for pediatric solid tumor database.

Key exclusion criteria

1)Patients with synchronous or metachronous concomitant malignancies.
2)Patients who are pregnant or breast feeding mother.
3)Patients with mental disorder who is considered inappropriate for study participation.
4)Patients with heart disease which required any therapy.
5)Patients with active infection which required any therapy.
6)Patients with any other inappropriate condition for study participation judged by physician.
7)HBs antigen positive.
HBs antigen negative but HBc antibody
or HBs antibody positive.( exclude HBs
antibody positive due to HBV
vaccination)
8)Patients who had continuous steroid therapy.

Target sample size

66

Name of lead principal investigator

1st name
Middle name
Last name	Hideki Sano

Organization

Fukushima Medical University

Division name

Department of pediatric oncology

Zip code

Address

1 Hikarigaoka, Fukushima city, Fukushima

TEL

024-547-1437

Email

s-hideki@fmu.ac.jp

Name of contact person

1st name
Middle name
Last name	Hideki Sano

Organization

Fukushima Medical University

Division name

Department of pediatric oncology

Zip code

Address

1 Hikarigaoka, Fukushima city, Fukushima

TEL

024-547-1437

Homepage URL

Email

s-hideki@fmu.ac.jp

Institute

Japan Ewing Sarcoma Study Group

Institute

Department

Personal name

Organization

Grant for Practical Research for Innovative Cancer Control from the Japan Agency for MedicalResearch and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Japan Children's Cancer Group (JCCG)

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

Date of disclosure of the study information

2016

Year

02

Month

05

Day

URL releasing protocol

http://jess-jccg.jp/member/

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

Open public recruiting

Date of protocol fixation

2015

Year

11

Month

30

Day

Date of IRB

Anticipated trial start date

2016

Year

02

Month

08

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

02

Month

05

Day

Last modified on

2017

Year

06

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024114