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Purpose of study:
The Children's Oncology Group is joining with several European cooperative groups for this study (Euro E.W.I.N.G –99).
The goals of this study are:
For COG subjects, to compare survival in a randomized study of standard drug therapy and whole lung irradiation versus high dose, intense drug therapy followed by replacement of peripheral blood stem cells (transplant). Some of the subjects in the European Cooperative Groups will also participate in this part of the study. The overall goal of the study is to improve the outcome of patients with Ewing sarcoma. ?
Who can participate:
Patients with isolated pulmonary or pleural metastases at the initial diagnosis of Ewing sarcoma.
Patients must be less than 50 years old at time of study enrollment.
What will happen during the study:
The treatment involves cancer fighting medicine called chemotherapy plus radiation therapy. All subjects will receive 6 courses of therapy with vincristine, ifosfamide, doxorubicin and etoposide (VIDE).
Some subjects will need early radiation therapy because of the location of their tumor. Some subjects will receive radiation therapy near the brain or spinal cord. Subjects who receive early radiation therapy or radiation therapy near the brain or spinal cord will be non-randomly assigned to receive standard therapy. Standard therapy consists of an additional 7 courses of therapy with vincristine, actinomycin-D and ifosfamide (VAI) following surgery (if surgery is possible). After completion of therapy with VAI, these subjects will also receive whole lung radiation therapy.
Most subjects will not require early radiation therapy or radiation therapy near the brain or spinal cord. These subjects will be eligible to be randomized to 1 of 2 therapies following surgery (if surgery is possible).The treatment plan that you receive is decided by a process called randomization. Randomization means that the treatment is assigned based on chance. It is a lot like flipping a coin, except that it is done by computer. You and your doctor will not pick which treatment you get. The randomization process is described in the COG Family Handbook for Children with Cancer.
The treatment plans are:
Standard therapy described above, or
Experimental therapy with intensive, high-dose chemotherapy followed by stem cell transplant.
You will be treated on this study for about 11 months if you receive the standard drug treatment and about 6-8 months if you receive the high-dose transplant treatment. However, subjects will continue to have physical exams and blood tests for a few years after treatment so that researchers can continue to observe any effects of treatment. In addition, we would like to continue to collect some information about how you are doing for as long as you allow us. ?
Who to contact:
PI: Mark Ranalli, MD