Ewing's Sarcoma (ES) Clinical Trial
— EW-2Official title:
Study With High Doses of Chemotherapy, Radiotherapy and Consolidation Therapy With Ciclofosfamide and Anticyclooxygenase 2, for the Metastatic Ewing Sarcoma
| Verified date | September 2022 |
| Source | Italian Sarcoma Group |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Study for the treatment of metastatic Ewing sarcoma with high doses chemotherapy, radiotherapy and maintenance therapy.
| Status | Completed |
| Enrollment | 155 |
| Est. completion date | April 29, 2022 |
| Est. primary completion date | April 29, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 40 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Centro di Riferimento Oncologico - Unit of Medical Oncology | Aviano | Pordenone |
| Italy | Azienda ospedaliero universitaria consorziale policlinico - bari | Bari | |
| Italy | Istituto Ortopedico Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors | Bologna | |
| Italy | Servizio di Oncoematologi Pediatrica Ospedale microcitemico ASL 8 | Cagliari | |
| Italy | I.R.C.C. - Unit of Medical Oncology | Candiolo | Torino |
| Italy | A.O. Universitaria Meyer | Firenze | |
| Italy | Istituto Giannina Gaslini | Genova | |
| Italy | Fondazione IRCCS INT Milano | Milano | |
| Italy | Azienda Ospedaliera di Padova | Padova | |
| Italy | Azienda Ospedaliero-Universitaria Pisana | Pisa | |
| Italy | Ospedale Pediatrico Bambin Gesu' | Roma | |
| Italy | Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology | Torino | |
| Italy | IRCCS materno infantile Burlo Garofolo | Trieste |
| Lead Sponsor | Collaborator |
|---|---|
| Italian Sarcoma Group |
Italy,
Gardner 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. — View Citation
Paulussen M, Ahrens S, Burdach S, Craft A, Dockhorn-Dworniczak B, Dunst J, Fröhlich B, Winkelmann W, Zoubek A, Jürgens 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. — View Citation
Picci P, Böhling 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall Survival (OS) | Evaluation of the OS in patients treated according to the protocol | Expected average 3 year | |
| Primary | Event Free Survival (DFS) | Evaluation of the time in which the patient do not experience any progression, relapse of toxicity event when treated according to the protocol | Expected average 1 year | |
| Secondary | Safety - Incidence and grade of treatment-emergent Adverse Events | Incidence and grade of treatment-emergent Adverse Events | every 21 days up to 1 year | |
| Secondary | Evaluation of Quality of life using Pediatric Quality of Life Inventory (PedQL) -in child and adolescents(EORTC QLQ-C30) for children and adolescents | Evaluation of patient's Quality of life: comparison of the Baseline and On treatrment quality of life score using PedQL | every 3 weeks for the first 6 months and 3 monthly up to 1 year | |
| Secondary | Evaluation of Quality of life using European Organisation for Research and Treatment of Cancer Quality of Life of Cancer Patients (EORTC QLQ-C30) for adult patients | Evaluation of patient's Quality of life: comparison of the Baseline and On treatrment quality of life score using EORTC QLQ-C30 | every 3 weeks for the first 6 months and 3 monthly up to 1 year |