Controlled, randomized phase III study, with the intent of optimizing the treatment of
not metastatic Ewing Sarcoma. The patients will be randomized into 2 arms: standard
treatment vs intensive treatment. Both arms will receive an induction treatment followed
by surgery (wherever is possible) and/or radiotherapy. The maintenance treatment will be
different on the basis of the response to the induction treatment (good or poor)

Efficacy of Dose Intensification in Patients With Non-metastatic Ewing Sarcoma

Ewing's Sarcoma

Eligible patients with non metastatic Ewing's Sarcoma will be randomized into 2 different
arms: standard treatment arm A (based on the ISG/SSG III protocol) or into the
experimental arm B(chemotherapy with dose intensification and shorter length of
treatment).

Both arm will receive an induction treatment with higher dose intensity of doxorubicin
and ifosfamide in Arm B.

After the induction treatment all the patient will undergo to local treatment (surgery
and/or radiotherapy)that will be followed by a maintenance therapy.

The maintenance therapy will be different for both arms and, within each arm, on the
basis of the response (histologically evaluated) of the pre-local treatment therapy.

Maintenance for Arm A: Poor responders will undergo to stem cells apheresis and their
reinfusion after treatment with high doses of Busulfan and Melphalan 25 weeks.

Good responders will receive a 6 drugs maintenance treatment for 37 weeks (as per
standard ISG/SSG III protocol)

Maintenance for Arm B: Poor responders will undergo to stem cells apheresis and their
reinfusion after an intensified treatment with high doses of Busulfan and Melphalan (25
weeks).

Good responders will receive a maintenance treatment for 25 weeks

The primary aim of the study is to assess the Event Free Survival (EFS) that is expected
to be similar in both arms

The secondary objectives are:

To assess if the induction treatment in Arm B is able to increase the percentage of good
responders compared to those who receive standard treatment.

To assess the toxicity and the Quality of Life related to the chemotherapy treatment

Standard treatment (as per protocol ISG SSG III)

Intensified chemotherapy

Phase III Study on Efficacy of Dose Intensification in Patients With Non-metastatic Ewing Sarcoma.

The EFS (event defined as Progressive Disease , onset of local relapse and/or metastasis,
death due to chemotherapy toxicity or for other causes) will be calculated from the first
treatment day up to the event onset or to last follow-up

The DFS will be calculated from the day that the patient will be free from disease
(surgery date and/or radiotherapy completion) up to the date of progression disease or
last follow-up

The Metastasis free Survival will be evaluated from the time of disease free (surgery
performed and/or radiotherapy completed) to the onset of distance metastasis or last
follow-up

The OS will be evaluated for the start treatment day to the day of death (for any causes)

Standard treatment for non metastatic Ewing's Sarcoma (as defined by the ISG/SSG III
protocol).

It is based on a 6 drugs pre-local treatment (Vincristin, dactinomycin,
cyclophosphamide,ifosfamide,etoposide and doxorubicin) followed by local treatment
(surgery and/or radiotherapy)and by a maintenance treatment based on induction response

Dose intense treatment for non metastatic Ewing's Sarcoma It is based on a 3 drug
pre-local treatment (Vincristin, ifosfamide and doxorubicin)followed by local treatment
(surgery and/or radiotherapy)and by a maintenance treatment based on induction response

Efficacy of Dose Intensification in Patients With Non-metastatic Ewing Sarcoma

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status