Clinical Research Study Viewer

AEWS1031: A Phase III Randomized Trial for Initial Treatment of Non-metastatic Ewing Sarcoma

Purpose of study:

In this study, researchers want to find out if we can improve the treatment for your disease by adding another drug called topotecan to the 5 drugs used in standard treatment.

We chose the drug topotecan because the combination of topotecan and cyclophosphamide has been found to be useful in treating some subjects with Ewing sarcoma when it has come back after treatment (recurrence). The combination of vincristine/topotecan/cyclophosphamide (VTC) has been well-tolerated in people with other types of sarcoma. A recent COG study added VTC to standard therapy for localized Ewing sarcoma and the early results indicate that VTC can be used in this way.

The overall goal of this study is:
To find if adding the drug combination VTC to the standard five-drug chemotherapy for Ewing sarcoma will get rid of the cancer better than the standard five-drug chemotherapy by itself. ?

Who can participate:

Diagnosis
Patients with newly diagnosed, biopsy confirmed, extracranial, non-metastatic Ewing sarcoma or PNET of bone or soft tissue are eligible for this study.
No prior chemotherapy or radiation therapy is allowed. Patients should only have had a biopsy of the primary tumor without an attempt at complete or partial resection. Patients will still be eligible if unplanned excision was attempted or accomplished as long as adequate imaging was obtained prior to surgery.

Age

Patient must be < 30 years of age at the time of study enrollment.

Additional screening for eligibility will be required.

What will happen during the study:

Random Assignment

Subjects (people participating in the study) will receive 1 of 2 different treatment plans. The treatment plan they 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 to make sure that there are about the same number of people on each treatment plan of the study. The randomization process is described in the COG Family Handbook for Children with Cancer. You will be randomized to get either standard chemotherapy (Regimen A) or experimental chemotherapy (Regimen B). The randomization takes place at the time you are enrolled on the study. You have an equal chance of getting either one of the treatments.

Treatment

The treatment plan involves chemotherapy along with surgery and/or radiation therapy. The treatment on this clinical trial may take about 9 months. The treatment is divided into 3 stages: Induction, Local control and Consolidation therapy.

  • Induction therapy is the use of chemotherapy to reduce/get rid of the cancer. The goal is to kill cancer cells and shrink the tumor so that the surgery/radiation therapy will be easier and safer.
  • Local control is treatment directly to the tumor, and will be surgery and/or radiation therapy.
  • Consolidation therapy is treatment intended to kill any remaining cancer cells so that the tumor is less likely to come back.

Each cycle of chemotherapy on this study will last 14 days. Induction will be 6 cycles of chemotherapy, and will last around 12 weeks. Local Control will begin upon recovery from Induction and may be surgery, radiation therapy, or both (as described below). That decision will be made by your doctors and will depend on the location and size of the tumor. Consolidation includes 11 cycles (22 weeks) of chemotherapy and may start during the period of Local Control. This means that sometimes radiation therapy and some chemotherapy will be given in the same weeks.

Local Control
If you are to have surgery only, this will happen after you recover from Induction therapy.

  • If you are to have radiation therapy only, it will likely be given during Weeks 1-7 of Consolidation.
  • If you are to have surgery first followed by radiation therapy, surgery will occur after you recover from Induction therapy. Radiation therapy will then begin after you recover from surgery.
  • If you are to have radiation therapy first followed by surgery, radiation therapy will be given during Weeks 1-7 of consolidation and surgery will happen after radiation is completed.

The exact timing of chemotherapy and local control will depend on how well you recover from the drugs given during each cycle. You will also need time to heal from any surgery, and from the effects of radiation therapy. ?

Timing

Subjects in this clinical trial are expected to receive treatment on this study for about 9 months. After treatment, subjects will have follow-up examinations and medical tests. We will continue to collect some medical information about how you are doing for 10 years from the time you start the study.

 

Who to contact:

PI: Mark Ranalli, MD

614-722-3563
Mark.Ranalli@nationwidechildrens.org
 

Nationwide Children's Hospital
700 Children's Drive Columbus, Ohio 43205 614.722.2000