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Phase II Prospective Multicenter Study of High-Dose Treosulfan/Melphalan as Consolidation Treatment in Newly Diagnosed High-Risk and Very High-Risk Ewing Sarcoma.

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518912-37-01
Acronym
INES
Enrollment
60
Registered
2024-12-09
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ewing Sarcoma

Brief summary

• Frequency, duration, and severity of Adverse Effects (AEs) and Serious Adverse Effects (SAEs) according to CTCAE v. 5.0 • Event-Free Survival at 36 months defined as the time from the start of chemotherapy to disease progression, relapse, second malignancies, death from treatment-related complications, or the last follow-up

Detailed description

Overall Survival at 36 months defined as the time from the start of chemotherapy to death or the last follow-up

Interventions

DRUGIFOSFAMIDE
DRUGDOXORUBICIN
DRUGMELPHALAN
DRUGVINCRISTINE
DRUGCYCLOPHOSPHAMIDE
DRUGETOPOSIDE

Sponsors

Fondazione Santobono Pausilipon Onlus
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
• Frequency, duration, and severity of Adverse Effects (AEs) and Serious Adverse Effects (SAEs) according to CTCAE v. 5.0 • Event-Free Survival at 36 months defined as the time from the start of chemotherapy to disease progression, relapse, second malignancies, death from treatment-related complications, or the last follow-up

Secondary

MeasureTime frame
Overall Survival at 36 months defined as the time from the start of chemotherapy to death or the last follow-up

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026