Ewing's Sarcoma Clinical Trial
Official title:
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
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.
n/a
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|---|---|---|---|
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| Completed |
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Phase 1/Phase 2 | |
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