Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas
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Clinical Trial: Sarcoma
A Study of a Short Course of Radiation for the Treatment of Soft Tissue Sarcoma
A sarcoma is a type of cancer that develops in certain tissues like bone or muscle, and is most common in the arms, legs, or the trunk (torso).
Radiation therapy given before or after surgery is a standard of care treatment option for patients with soft tissue sarcomas. Typical radiation treatment for sarcoma involves a “long-course” schedule, where many small doses of radiation are delivered over a period of about 5 weeks. The length of time this treatment requires can be a significantly disruptive to patients’ lives, especially when having to travel from a long distance to the treatment center.
This study will deliver radiation prior to surgery, giving five large doses of radiation over a period of about five days. This “short-course” schedule is called “hypofractionation.”
The study is designed to discover the tolerability and side effects of this short course of radiation treatment, and it is hoped that this short-course schedule will provide the same or superior outcomes for patients over the more common long-course treatment schedule.
Prior to treatment, subjects will have a routine planning session, which includes a CT scan and/or MRI to visualize the part of the body to be treated. About one week later, subjects will begin their radiation treatment, which provides five large doses of radiation over a period of about five days.
Subjects will then undergo routine surgery for their sarcoma, which typically occurs within 2 – 12 weeks after the radiation.
Regular follow-up visits to the Department of Radiation Oncology will including physical exams and blood draws which occur about once every few months.
Eligibility Criteria (Basic):
- Must be planning to receive routine pre-operative radiotherapy.
- Patients who have already received radiation to the area to be treated are excluded.
- Patients who are planning to receive chemotherapy at the time of radiation are excluded.
- Must be 18 years of age or older.
Other eligibility criteria exist.
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