Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Sarcoma

Sarcoma, Ewing

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Osteosarcoma

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Soft Tissue Sarcoma

Ewing Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Cardiotonic Agents

Etoposide

Gemcitabine

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Docetaxel

Vincristine

Ifosfamide

Etoposide phosphate

Isophosphamide mustard

Dexrazoxane

Razoxane

Mesna

Standard risk patients: MP6 Treatment:

CHEMOTHERAPY: 2 cycles of vincristine-doxorubicin + dexrazoxane-cyclophosphamide, 1 cycle of ifosfamide-etoposide. SURGERY: Ideally within 21 days after chemotherapy.

CHEMOTHERAPY: 1 cycle of vincristine-doxorubicin + dexrazoxane-cyclophosphamide, 1 cycle of ifosfamide-etoposide.

RADIOTHERAPY: On the primary tumor bed in case of unresectable tumors, resected tumors with inadequate margins, or those with histologic response \<90%.

High risk patients:

CHEMOTHERAPY: Window phase with 2 cycles of gemcitabine + docetaxel. MP6 TREATMENT. CHEMOTHERAPY: Maintenance therapy for 1 year with gemcitabine + docetaxel.

* Vincristine, 2 mg/m\^2 IV bolus, day 1.
* Doxorubicin: 75 mg/m\^2 per cycle, or 25 mg/m\^2/day x 3 days, IV infusion, 1 hour (after dexrazoxane administration at the dose of 10:1).
* Dexrazoxane: administered at a dose of 10:1, before doxorubicin only in adults.
* Cyclophosphamide: 2100 mg/m\^2 IV infusion, 6 hours, with MESNA protection, days 1 and 2.
* MESNA: used with cyclophosphamide and ifosfamide. The total daily dose of MESNA is equivalent to at least 60% of the daily dose of cyclophosphamide or ifosfamide.
* G-CSF: 5 micrograms/kg/day SC. It starts 24 hours after the last dose of chemotherapy and continues until the absolute neutrophil count is ≥ 750 mm\^3/L.
* Ifosfamide: 1800 mg/m\^2/day IV infusion, 1 hour, days 1-5 of each cycle (9,000 mg/m\^2 total maximum dose).

Window phase in high-risk patients (21-days cycle):

* Gemcitabine: 1000 mg/m\^2 IV, 90 minutes on day 1 and 8.
* Docetaxel 100 mg/m\^2, 2-3 hour infusion on day 8.

Chemotherapy

Surgical intervention aiming to completely resect the tumor with negative margins.

Surgery

On the primary tumor bed in case of unresectable tumors, resected tumors with inadequate margins, or those with histologic response \<90%. Patients will receive radiotherapy 21 days after the completion of chemotherapy.

Radiotherapy

Jaume Mora Graupera, MD

Tumors of the Ewing sarcoma family (ES) affect children, adolescents and young adults. The reported incidence is 0.6 cases per million inhabitants every year. The peak incidence occurs between 10 and 20 years and it is rarely diagnosed beyond 30. The ES is a severe disease with a progression-free survival after 5 years of 60% in cases without metastasis and deadly in the majority of patients presenting metastasis. The ES is considered a systemic disease because, despite receiving an adequate local treatment, over 90% of patients deaths occur due to disseminated disease. Combined therapy of surgery, radiotherapy and chemotherapy has led to an improvement in the prognosis, achieving a survival of about 60% in most series

The MSKCC P6 protocol was developed for the treatment of high risk ES. In 2003, Kolb et al. reported the MSKCC experience after a 4-years follow-up of 68 patients who had been included from 1990 to 2001. Following the MSKCC P6 protocol, a survival rate of 82% was achieved in patients without metastasis, superior to the achieved with less intensive protocols. Following the guidelines of the MSKCC P6 protocol, in 2002 we modified the treatment schedule to create the modified P6 protocol (MP6). GEIS intends to develop MP6 as a clinical trial, which could provide the following potential advantages about current treatments:

1. Lower total dose of alkylating agents.
2. Early cardioprotection with dexrazoxane.
3. Radiotherapy adjusted to the initial response.
4. Pilot trial with the combination of Gemcitabine + Docetaxel for high-risk patients.

Study of Intensive Chemotherapy, Surgery and Radiotherapy to Treat Ewing's Sarcoma in Children and Young Adults

Phase 2, Open-label, Uncontrolled, Multicenter and Prospective Study of Intensive Chemotherapy, Surgery and Radiotherapy to Treat Ewing's Sarcoma in Children and Young Adults

Assessment of the progression free survival in all the patients enrolled in the study 3 years after the completion of the treatment under study.

To assess the objective response rate to treatment (ORR) defined following EMEA criteria (CPMP/EWP/205/95/Rev.3/Corr.2) in high risk patients with Ewing's sarcoma treated with an early window phase of Gemcitabine + docetaxel (G + D).

To assess the disease progression, aiming to reach an index of disease progression \< 20% for high risk patients during the maintenance phase with Gemcitabine + Docetaxel.

To evaluate the toxicity and tolerance to the treatment Gemcitabine + Docetaxel in high risk patients, and toxicity and tolerance of mP6 treatment in all patients.

Molecular diagnosis and extension study of bone marrow in all patients included in the trial. Assessment of prognostic significance of the type of translocation and the molecular effect in the bone marrow.

Creation of a cohort of patients treated with anthracyclines at high doses and early cardioprotection with dexrazoxane (Cardioxane). Long-term study of cardioprotection in these patients compared with historical series from the P6 protocol that did not received cardioprotection.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Intensive Chemotherapy, Surgery and Radiotherapy to Treat Ewing's Sarcoma in Children and Young Adults	NCT01696669	Ewing's Sarcoma	Chemotherapy Surgery Radiotherapy	- 40 Years	Grupo Espanol de Investigacion en Sarcomas
Study of Intensive Chemotherapy, Surgery and Radiotherapy to Treat Ewing's Sarcoma in Children and Young Adults	NCT01696669	Ewing's Sarcoma	Chemotherapy Surgery Radiotherapy	- 40 Years	Grupo Espanol de Investigacion en Sarcomas

Spots Global Cancer Trial Database for p6 protocol mskcc