JESS14

Phase 2

Recruiting

• Conditions: Ewing sarcoma family tumor; Ewing sarcoma; C04.557.450.565.575.650.800

• Registration Number: JPRN-jRCTs021180022
• Lead Sponsor: Sano Hideki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-25
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

1. Histologically confirmed 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.
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

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
3year progression-free survival

Secondary Outcome Measures

Name	Time	Method
3year overall survival, Completion rate of Induction<br>Rate of the patients who can complete 6 cycles of Induction VDC-IE within 14 weeks.<br>Treatment interval (days) on each chemotherapy cycles.<br>Response rate after Induction.<br>Adverse event<br>Pathological Response Rate<br>Completion rate of 14 cycles chemotherapy.<br>Dose of chemotherapeutic agent.