UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020903 |
|---|---|
| Receipt number | 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 15:13:10 |
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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
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
s-hideki@fmu.ac.jp
Sponsor or person
Institute
Japan Ewing Sarcoma Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024114
