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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020903
Receipt No. R000024114
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
Date of disclosure of the study information 2016/02/05
Last modified on 2017/06/15

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Basic information
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
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
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

Public contact
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

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)

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

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

Related information
URL releasing protocol http://jess-jccg.jp/member/
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 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
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/ctr_e/ctr_view.cgi?recptno=R000024114

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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