UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	Interval Compressed VDC-IE for Non-metastatic ESFT (JESS14)
Region	Japan

Condition
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

Objectives
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

Assessment
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.

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
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

Eligibility
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

Research contact person
Name of lead principal investigator	Hideki Sano
Organization	Fukushima Medical University
Division name	Department of pediatric oncology
Address	1 Hikarigaoka, Fukushima city, Fukushima
TEL	024-547-1437
Email	s-hideki@fmu.ac.jp

Public contact
Name of contact person	Hideki Sano
Organization	Fukushima Medical University
Division name	Department of pediatric oncology
Address	1 Hikarigaoka, Fukushima city, Fukushima
TEL	024-547-1437
Homepage URL
Email	s-hideki@fmu.ac.jp

Sponsor
Institute	Japan Ewing Sarcoma Study Group
Institute
Department

Funding Source
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

Other related organizations
Co-sponsor	Japan Children's Cancer Group (JCCG)
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

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 05 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 11 Month 30 Day
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

Related information
URL releasing protocol	http://jess-jccg.jp/member/
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 02 Month 05 Day
Last modified on	2017 Year 06 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024114