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Study for the treatment of metastatic Ewing sarcoma with high doses chemotherapy, radiotherapy and maintenance therapy.
Study for the treatment of Ewing metastatic sarcoma with and induction phase with Vincristine (VIN), Adriamycin (ADM), Ciclofosfamide(CYC), Ifosfamide(IFO), Etoposide(ETO) and radiotherapy (RT)followed by a consolidation phase with Busulfan and Melfalan (BUMEL) and Peripheral Blood Stem Cells Transplantation (PBSCT) and a subsequent maintenance phase with Ciclofosfamide and Celecoxib for High Risk (HR) patients.
Very High Risk (VHR) patients will receive a prior frontline therapy with Temozolomide and Irinotecan (TEMIRI), while patient with lung metastasis only will undergo to total lung irradiation after PBSCT
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEMIRI+VIN+ADM+IFO+ CYC+ETO+BUMEL | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEMIRI | Drug | Window therapy frontline for VHR patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Evaluation of the OS in patients treated according to the protocol | Expected average 3 year |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety - Incidence and grade of treatment-emergent Adverse Events | Incidence and grade of treatment-emergent Adverse Events | every 21 days up to 1 year |
| Evaluation of Quality of life using Pediatric Quality of Life Inventory (PedQL) -in child and adolescents(EORTC QLQ-C30) for children and adolescents |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roberto Luksch, MD | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro di Riferimento Oncologico - Unit of Medical Oncology | Aviano | Pordenone | 33081 | Italy | ||
| I.R.C.C. - Unit of Medical Oncology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9193352 | Background | Picci 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. | |
| 18246113 |
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| ID | Term |
|---|---|
| D012512 | Sarcoma, Ewing |
| ID | Term |
|---|---|
| D012516 | Osteosarcoma |
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
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| ID | Term |
|---|---|
| D000077204 | Temozolomide |
| D000077146 | Irinotecan |
| D004317 | Doxorubicin |
| D007069 | Ifosfamide |
| D003520 | Cyclophosphamide |
| D005047 | Etoposide |
| D002066 | Busulfan |
| D008558 | Melphalan |
| D014750 | Vincristine |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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| ADM | Drug | Drug used in the Induction phase in association with Vincristine, Ifosfamide, cyclophosphamide and Etoposide |
|
|
| IFO | Drug | Drug used in the Induction phase in association with Vincristine, Adriamycin, cyclophosphamide and Etoposide |
|
|
| CYC | Drug | Drug used in the Induction phase in association with Vincristine, Ifosfamide, Adriamycin and Etoposide |
|
|
| ETO | Drug | Drug used in the Induction phase in association with Vincristine, Ifosfamide, cyclophosphamide and Adriamycin |
|
|
| BUMEL | Drug | Consolidation phase |
|
|
| VIN | Drug | Drug used in the Induction phase in association with cyclophosphamide , Ifosfamide, Adriamycin and Etoposide |
|
|
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 |
| 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 |
| Candiolo |
| Torino |
| 10060 |
| Italy |
| Azienda ospedaliero universitaria consorziale policlinico - bari | Bari | 70124 | Italy |
| Istituto Ortopedico Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors | Bologna | 40136 | Italy |
| Servizio di Oncoematologi Pediatrica Ospedale microcitemico ASL 8 | Cagliari | Rosamaria | Italy |
| A.O. Universitaria Meyer | Florence | 50139 | Italy |
| Istituto Giannina Gaslini | Genova | Italy |
| Fondazione IRCCS INT Milano | Milan | Italy |
| Azienda Ospedaliera di Padova | Padova | 35128 | Italy |
| Azienda Ospedaliero-Universitaria Pisana | Pisa | 56126 | Italy |
| Ospedale Pediatrico Bambin Gesu' | Roma | Italy |
| Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology | Torino | 10126 | Italy |
| IRCCS materno infantile Burlo Garofolo | Trieste | 34137 | Italy |
| Background |
| 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. |
| 9602261 | Background | Paulussen 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. |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D012509 | Sarcoma |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D010078 | Oxazines |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D005960 | Glucosides |
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D008698 | Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |