Clinical trial · Interventional
Protocol for the Treatment of Metastatic Ewing Sarcoma
Study With High Doses of Chemotherapy, Radiotherapy and Consolidation Therapy With Ciclofosfamide and Anticyclooxygenase 2, for the Metastatic Ewing Sarcoma
NCT02727387CI-TRIAL-00060916EW-2completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Study for the treatment of metastatic Ewing sarcoma with high doses chemotherapy, radiotherapy and maintenance therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ewing's Sarcoma (ES) | Ewing Sarcoma | ALIAS | 0.85 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ADM | Drug | — | UNRESOLVED |
| BUMEL | Drug | — | UNRESOLVED |
| CYC | Drug | — | UNRESOLVED |
| ETO | Drug | — | UNRESOLVED |
| IFO | Drug | — | UNRESOLVED |
| TEMIRI | Drug | — | UNRESOLVED |
| VIN | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TEMIRI+VIN+ADM+IFO+ CYC+ETO+BUMEL
- description
- 2cycles of Temozolomide(500 mg/m2)+Irinotecan(250 mg/m2) and 2cycles of Vincristine(1.4mg/m2)+ Adriamycin(90mg/m2)+Ifosfamide (9gr/m2) alternes with 2 cycles of Ciclofosfamide(4g/m2)+Etoposide (600mg/m2) followed by radiotherapy (42-54 Gy) and 2cycles of Ifosfamide (9gr/m2) + Etoposide(300mg/m2) alternes with to 2cycles of Vincristine (1.4mg/m2)+ Adriamycin (80mg/m2)+ Ciclofosfamide(1.2g/m2) and Busulfan(0.8-1.2 mg/Kg)+Melfalan(140 mg/m2)+PBSCT and 6 months with Celecoxib (500mg/m2/die for\<14 years old ,800 mg/die for\>14 years old) Ciclofosfamide (oral therapy 35mg/m2/die for\<14 years old, 50 mg/m2 for\>14 years old)
- interventionNames
- Drug: TEMIRI
- Drug: ADM
- Drug: IFO
- Drug: CYC
- Drug: ETO
- Drug: BUMEL
- Drug: VIN
Primary outcomes (2)
- measure
- Overall Survival (OS)
- timeFrame
- Expected average 3 year
- description
- Evaluation of the OS in patients treated according to the protocol
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven Ewing's sarcoma * Age ≤ 40 years * No previous treatment * Multiple skeletal metastasis or bone marrow infiltration , with/without lung/pleural metastasis * Signed Informed Consent Exclusion Criteria: * Localized Ewing's sarcoma * Any contraindications to the study treatment * Female patients who not accept to use an effective birth control method. * Pregnant or breast-feeding patients
References
Publications (3)
- BACKGROUNDPicci P, Bohling T, Bacci G, Ferrari S, Sangiorgi L, Mercuri M, Ruggieri P, Manfrini M, Ferraro A, Casadei R, Benassi MS, Mancini AF, Rosito P, Cazzola A, Barbieri E, Tienghi A, Brach del Prever A, Comandone A, Bacchini P, Bertoni F. Chemotherapy-induced tumor necrosis as a prognostic factor in localized Ewing's sarcoma of the extremities. J Clin Oncol. 1997 Apr;15(4):1553-9. doi: 10.1200/JCO.1997.15.4.1553. PMID 9193352
- BACKGROUNDGardner SL, Carreras J, Boudreau C, Camitta BM, Adams RH, Chen AR, Davies SM, Edwards JR, Grovas AC, Hale GA, Lazarus HM, Arora M, Stiff PJ, Eapen M. Myeloablative therapy with autologous stem cell rescue for patients with Ewing sarcoma. Bone Marrow Transplant. 2008 May;41(10):867-72. doi: 10.1038/bmt.2008.2. Epub 2008 Feb 4. PMID 18246113
- BACKGROUNDPaulussen M, Ahrens S, Burdach S, Craft A, Dockhorn-Dworniczak B, Dunst J, Frohlich B, Winkelmann W, Zoubek A, Jurgens H. Primary metastatic (stage IV) Ewing tumor: survival analysis of 171 patients from the EICESS studies. European Intergroup Cooperative Ewing Sarcoma Studies. Ann Oncol. 1998 Mar;9(3):275-81. doi: 10.1023/a:1008208511815. PMID 9602261