IRB Number:

07-002378

Trial Status:

Open for Enrollment

Phase: III

Why is this study being done?

Patients are being asked to take part in this study because they have a type of cancer called a non-rhabdomyosarcoma soft tissue sarcoma (NRSTS). Non-rhabdomyosarcoma soft tissue sarcomas are rare tumors and little is known about them. At the present time, doctors do not always know what the best treatment will be for a patient with one of these tumors. Studies done in both children and adults with NRSTS have shown that the amount of treatment a patient needs may be based on the risk group of the tumor.

Tumors are assigned a risk group based on features that influence how they behave. For NRSTS, the risk group is based on the type of cells in the tumor (the grade of the tumor), the size of the tumor, if the tumor has spread to other areas of the body, and how much of the tumor can be taken out by surgery. Patients with tumors in the low risk group may be cured with mild treatment, in some cases only surgery. Patients with tumors in the intermediate and high risk groups may need more treatment, including anti-cancer drugs (chemotherapy) and high energy X-ray therapy (radiation therapy).

It is common to enroll children and adolescents with cancer in a clinical trial that seeks to improve cancer treatment over time. Clinical trials include only people who choose to take part. Patients have a choice between a standard treatment for NRSTS and this clinical trial. Patients with NRSTS are commonly treated with surgery, radiation therapy and/or chemotherapy. The type(s) of treatment used depend on the type of tumor and the risk group.

Who is Eligible to Participate in the Study?

-Diagnosed with non-rhabdomyosarcoma soft tissue sarcoma (NRSTS)
-Patient's age less than 30 at the time of the biopsy that established the diagnosis of NRSTS
-No prior chemotherapy
-No prior radiotherapy to tumor-involved sites
-Prior use of steroids is acceptable

More specific, detailed eligibility and/ or exclusion criteria are associated with this trial.

What is Involved With this Study?

Patients in this study will be divided into four treatment groups:
1. Treatment Arm A - These patients have tumors that can be taken out with surgery. Some patients with lower risk tumors that can almost completely be taken out by surgery are also included. Patients on this treatment arm will not receive any other treatment (chemotherapy or radiation therapy). They will be watched for any evidence that the tumor has returned.

2. Treatment Arm B - These patients have higher risk tumors that can almost completely be taken out by surgery. They will have radiation therapy because there are tumor cells at the edges of the tissue taken out during surgery. Previous studies have shown that radiation therapy is necessary for these patients.

3. Treatment Arm C - These patients will have chemotherapy because the tumor has high risk features (large size and high grade) and has been completely (or almost completely) taken out, or because the tumor has spread to other parts of the body even though the original tumor has been completely (or almost completely) taken out. These patients will also get radiation therapy. Patients whose tumor has spread to other sites in the body will have surgery and/or radiation therapy at those sites after all the planned study therapy is done.

4. Treatment Arm D - These patients will get chemotherapy because the tumor has high risk features (large size and high grade) and has not been taken out with surgery. Patients whose tumor has spread to other parts of the body and whose original tumor has not been completely taken out with surgery will also get chemotherapy. All of the patients on this treatment arm will get radiation therapy. The amount of radiation depends on how much of the tumor can be taken out with surgery after some chemotherapy and radiation therapy is given.

Patients whose tumor has spread to other sites in the body will get surgery and/or radiation therapy to those sites at the end of all the study therapy.

Patients will be watched closely during therapy; if the tumor gets larger or disappears and then comes back, they will be taken off study therapy and their study doctor will talk to the patient about different therapy.

If patients are going to get chemotherapy and radiation therapy on this study, they will need to have the following exams and tests to find out if they can get the study therapy. These exams and tests are part of regular cancer care and may be done even if the patient does not join the study. If the patient has had some of them recently, they may not need to be repeated.

This will be up to the study doctor.
- Physical examination
- Blood tests
- Urinalysis
- Pregnancy test
- Heart function tests (for example, echocardiogram or MUGA, EKG)
- Lung function tests, if the tumor is near the lungs

If patients are going to get radiation therapy on this study, they should have a consultation with a radiation oncologist either before beginning the study or within one week of starting treatment.

While patients are on the study they will need these tests and procedures that are part of regular cancer care. They may be done more often because they are in this study.
- Blood tests
- Urinalysis
- Imaging studies (CT/MRI/bone scan)
- Heart function tests (for example, echocardiogram or MUGA, EKG)
- Lung function tests, if the tumor is near the lungs

How long will the Study run?

Treatment Arm A: Patients will be observed and the study doctor will ask them to visit the office for follow-up exams for at least 5 years. If at any time there are any signs that the disease has come back, their doctor will discuss treatments with the patient.

Treatment Arm B: Patients will get radiation therapy on this study for about six weeks. After they are finished with the radiation therapy, the study doctor will ask the patient to visit the office for follow-up exams for at least five years. If at any time there are any signs that the disease has come back, their doctor will discuss other treatments with the patient.

Treatment Arm C: Patients will be asked to take the study drugs for about five months. After they are finished taking the study drugs, the study doctor will ask the patient to visit the office for follow-up exams for at least five years. If at any time there are any signs that the disease has come back, their doctor will discuss other treatments with the patient.

Treatment Arm D: Patients will be asked to take the study drugs for about six months. After they are finished taking the study drugs, the study doctor will ask the patient to visit the office for follow-up exams for at least five years. If at any time there are any signs that the disease has come back, their doctor will discuss other treatments with the patient.

No matter which treatment arm patients were on, the research staff would like to continue to find out about the patient's health every year until 10 years after all the patients have been enrolled on the study. Keeping in touch with the patient and checking on how their health is will help the research staff to understand the long-term effects of the treatment.

Sponsor(s): Children's Oncology Group

Study Activation/Registration Date: 05/16/2007

IRB Review and Approval Date: 05/15/2007

Study Type: Treatment

Projected Accrual: The plan is to have up to 865 patients participate from multiple medical centers; 15 at Mayo Clinic.

Costs of Study:There may be standard patient care costs related to participating in a cancer research study.

Principal Investigator: Carola A.S. Arndt, MD

Who can I Contact for Additional Information on this Trial?

Complete Request Form for Cancer Clinical Trial Information at Mayo Clinic or
For more information about this study or other clinical trial options, please contact our Mayo Clinic Cancer Center Clinical Trials Referral Office.

• Patients living within the United States, call 507-538-7623, or e-mail cancerclinicaltrials@mayo.edu


• Patients living outside the United States may call our International Office at 507-284-8884, or e-mail intl.mcr@mayo.edu.

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 05/08/2008