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A multicenter national research study to evaluate use of presurgical, IGRT for soft tissue sarcomas, is being led by Dian Wang, M.D., Ph.D., a Medical College of Wisconsin radiation oncologist at Froedtert Hospital. This Radiation Therapy Oncology Group study will enroll approximately 102 adult patients with a confirmed diagnosis of soft tissue sarcoma of the arm or leg. Half of these participants will receive presurgical chemotherapy in addition to image-guided radiation therapy, based on an individual, preliminary decision made with their physician.

When treated with surgery alone, many soft-tissue sarcomas have a high risk of recurrence. Radiation therapy is frequently used in addition to surgery to reduce chances of recurrence. However, radiation can have long-term side effects on normal tissues surrounding the tumor, such as swelling, scarring and joint stiffness.

Recently, there have been advances in the way that radiation can be delivered, including the ability to precisely locate the tumor using image guided radiation therapy (IGRT). This makes it possible to administer radiation over a smaller area surrounding the tumor, with less radiation to surrounding normal tissues. The purpose of this study is to find out what effects, good and/or bad, IGRT has on patients and their tumors. It will determine if IGRT decreases long-term side effects of radiation on normal tissues and if IGRT reduces the chances of sarcoma recurring, when compared to the larger radiation fields used in prior studies.

Potential subjects will undergo preliminary clinical, laboratory, and contrast-enhanced CT and MRI scans. Eligible subjects will receive 22-25 days of outpatient radiation, once a day, Monday through Friday, and have surgery four to eight weeks after radiation therapy is complete. They will also undergo weekly physical exams, blood tests and functional assessments during radiation therapy, and repeat MRI or CT with contrast scans before surgery. Patients in the chemotherapy group will also have physical exams and blood tests before each chemotherapy cycle and blood tests weekly during chemotherapy.

Submission of tumor tissue obtained at the time of biopsy or surgery for review is also required of both groups. Patients with tumor cells at the edges of tissue removed in surgery will either receive a large dose of radiation during surgery, or one-to-two smaller treatments per day, for up to eight treatments, after surgery.

All participants will be checked every three months in years one and two, every six months in years three to five, and then once a year for life, with a physical exam, functional assessment, evaluation of any side effects they may be experiencing and blood tests. They will also undergo an MRI or CT scan with contrast, of their tumor, and a chest CT scan every six months, in years one and two, and once a year every year thereafter.

Source: Medical College of Wisconsin