A Phase I Study of Post-Operative Concurrent Chemoradiation for Extremity and Trunk Soft Tissue Sarcoma
Doxorubicin is a drug that is commonly used to treat certain kinds of cancer.
Before the start of treatment, you will have a physical exam. You will have blood (around 2
tablespoons) and urine tests. You will have a chest x-ray and a MRI of the tumor site. If
the doctor feels it is necessary, you will have a CT scan of the abdomen, an echocardiogram,
and/or a MUGA scan. Women who are able to have children must have a negative blood
The radiation treatment and chemotherapy will start around 4-6 weeks after surgery. During
the study, you will receive radiation treatments 5 days a week for 6 - 61/2 weeks. On Day 1
of each week of radiation therapy, you will be given doxorubicin through a continuous
injection into a vein for 4 days in a row. A special tube is placed into a large vein in
the neck or chest region or through a large vein in the arm. This is called a central venous
line. A small pump is then used to give the drug. This pump is about the size of a pack
of cigarettes. You will receive appropriate instructions for the maintenance of the pump.
The doxorubicin and radiotherapy will be given on an outpatient basis at M. D. Anderson.
If the disease gets worse or you experience any intolerable side effects, chemotherapy
and/or radiation therapy may be stopped and you may be taken off the study. At that time,
your doctor will discuss other treatment options with you.
Before the start of each week of treatment, you will have a physical exam and blood tests
(around 2 tablespoons). You will also have a MRI to check on the status of the disease.
After the study, you will have follow-up visits at M. D. Anderson every 3-4 months for the
first 2 years after the study then every 6 months for the next 3 years. After that you will
have follow-up visits once a year for the rest of your life to check on the status of the
disease. At every follow-up visit you will have ultrasound scans. You will have a MRI at
the first follow-up visit then only when the doctor feels it is necessary.
This is an investigational study. Doxorubicin is FDA approved and is commercially
available. Up to 30 patients will take part in this study. All will be enrolled at M. D.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To learn if the combination of radiation therapy plus low dose doxorubicin chemotherapy given after surgery is effective in the treatment of sarcoma.
Peter W. Pisters, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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