Clinical trial · Interventional
Efficacy of Dose Intensification in Patients With Non-metastatic Ewing Sarcoma
Phase III Study on Efficacy of Dose Intensification in Patients With Non-metastatic Ewing Sarcoma.
NCT02063022CI-TRIAL-00060924EW-1completedPhase 3ClinicalTrials.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)
Controlled, randomized phase III study, with the intent of optimizing the treatment of not metastatic Ewing Sarcoma. The patients will be randomized into 2 arms: standard treatment vs intensive treatment. Both arms will receive an induction treatment followed by surgery (wherever is possible) and/or radiotherapy. The maintenance treatment will be different on the basis of the response to the induction treatment (good or poor)
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 | Ewing Sarcoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intensified chemotherapy | Drug | — | UNRESOLVED |
| Standard treatment (as per protocol ISG SSG III) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard treatment (as per ISG SSG III protocol)
- description
- Standard treatment for non metastatic Ewing's Sarcoma (as defined by the ISG/SSG III protocol). It is based on a 6 drugs pre-local treatment (Vincristin, dactinomycin, cyclophosphamide,ifosfamide,etoposide and doxorubicin) followed by local treatment (surgery and/or radiotherapy)and by a maintenance treatment based on induction response
- interventionNames
- Drug: Standard treatment (as per protocol ISG SSG III)
- type
- EXPERIMENTAL
- label
- Intensified treatment
- description
- Dose intense treatment for non metastatic Ewing's Sarcoma It is based on a 3 drug pre-local treatment (Vincristin, ifosfamide and doxorubicin)followed by local treatment (surgery and/or radiotherapy)and by a maintenance treatment based on induction response
- interventionNames
- Drug: Intensified chemotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria * Ewing Sarcoma or PNET diagnosis centrally confirmed * Age ≤ 40 years * Absence of evident metastasis or lung met \< 0.5 cm Presence of skip metastasis in the bone compartment of the primary tumor is to be considered as local disease and not metastatic. * Adeguate bone marrow, hepatic and renal function * Left Ventricular Ejection Fraction \> 50% * No primary Ewing Sarcoma treatments (both chemotherapy and/or radiotherapy) * Voluntarily signed an informed consent form * Radiological and histological documentation available for central review. Exclusion Criteria * Presence of lung or extra-pulmonary lesions * Bone Marrow involvement * In case of chest disease: presence of plural effusion * Elapsed time between histological diagnosis and chemotherapy start, more than 4 weeks * Any medical contraindication to the use of the study drugs * Any psychological or social conditions that can compromise the protocol compliance and/or follow-up * Previous malignancies (excluded in situ cervix carcinoma)
References
Publications (2)
- BACKGROUNDS. Ferrari, T. Alvegard, R. Luksch, A. Tienghi, K. S. Hall, G. Bernini, A. Brach del Prever, P. Picci, G. Bacci, S. Smeland Non-metastatic Ewing's family tumors: High-dose chemotherapy with stem cell rescue in poor responder patients. Preliminary results of the Italian/Scandinavian ISG/SSG III protocol. J Clini Oncol, 2007 ASCO Annual Meeting Proceedings Vol 25 (June 20 Suppl), 2007: 10014
- DERIVEDLuksch R, Palmerini E, Milano GM, Paioli A, Asaftei S, Barretta F, Puma N, Cesari M, Tirtei E, Podda M, Pierobon M, Manzitti C, Ferraresi V, Tamburini A, Bertulli R, Di Pinto D, Mascarin M, Grignani G, Coccoli L, Rabusin M, De Leonardis F, Gambarotti M, Parafioriti A, Cammelli S, Vennarini S, Ferrari S, Donati DM, Bastoni S, Massimino M, Fagioli F, Ibrahim T. Intensified Induction Therapy for Newly Diagnosed, Localized Skeletal Ewing Sarcoma (ISG/AIEOP EW-1): A Randomized, Open-Label, Phase 3, Non-Inferiority Trial. Pediatr Blood Cancer. 2025 Apr;72(4):e31551. doi: 10.1002/pbc.31551. Epub 2025 Jan 20. PMID 39833645