JESS14

JRCT ID: jRCTs021180022

Registered date:25/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Ewing sarcoma family tumor
• Date of first enrollment: 22/02/2016
• Target sample size: 66
• Study type: Interventional

Intervention(s)

Chemotherapy
Standard therapy for localized Ewing sarcoma is VDC-IE with 3 weeks interval. Protocol treatment will consist of Induction, Local Control and Consolidation therapy. All patients will receive total of 14 cycles of chemotherapy; each cycle will be 2 weeks duration in this study. Induction consist of six cycles (12 weeks) of chemotherapy and will be delivered prior to local control therapy which may involve surgery and/or radiation therapy. before local therapy. Consolidation therapy will consist of the eight cycles (16 weeks) of chemotherapy. VDC consists of cyclophosphamide1200mg/m2, doxorubicin75mg/m2, and vincristine1.5mg/m2. IE consists of ifosfamide 9000mg/m2 and etoposide 500 mg/m2. The chemotherapy cycles alternate between VDC and IE with biweekly interval using G-CSF.

Local Control Therapy
This study requires definitive treatment of the primary tumor with complete surgical excision, a combination of surgical excision and radiation therapy for microscopic residual disease, or full dose radiation therapy for inoperable tumor.
See treatment schema.

Outcome(s)

• Primary Outcome: 3year progression-free survival

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: < 50age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Sano Hideki
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development,Authorized nonprofit organization Gold Ribbon Network,Children's Cancer Association of Japan
• Secondary ID(s): UMIN000020903