Non-metastatic Ewing Sarcoma Family Tumor
Conditions
Interventions
Chemotherapy 1)VDC therapy 2)IE therapy 3)VC therapy Surgery Radiotherapy
Sponsors
Japan Ewing Sarcoma Study Group
Japan Children'
s Cancer Group (JCCG)
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactHideki Sano
Fukushima Medical University Department of pediatric oncology
Outcome results
None listed