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
Phase 2
Recruiting
- Conditions
- on-metastatic Ewing Sarcoma Family Tumor
- Registration Number
- JPRN-UMIN000020903
- Lead Sponsor
- Japan Ewing Sarcoma Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 66
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 3-year progression free survival
- Secondary Outcome Measures
Name Time Method 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.