NCT01696669

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Grupo Espanol de Investigacion en Sarcomas · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Ewing's Sarcoma

Interventions

Type	Name	Description
DRUG	Chemotherapy	* 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.
PROCEDURE	Surgery	Surgical intervention aiming to completely resect the tumor with negative margins.
RADIATION	Radiotherapy	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.

Timeline

• Start date: 2010-03-30
• Primary completion: 2017-12-20
• Completion: 2018-01-18
• First posted: 2012-10-01
• Last updated: 2018-08-01

Locations

9 sites across 1 country: Spain