Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas: Expansion Cohort
Radiation therapy in either the pre-operative or post-operative setting is a standard of care treatment option for patients with soft tissue sarcomas based on randomized Level 1 evidence. Pre-operative radiation therapy has advantages over post-operative treatment. Patients receiving preoperative treatment, for example, have a lower chance of developing long-term toxicities, such as swelling, fibrosis and joint mobility. Standard preoperative radiation therapy involves daily treatments for 5 long weeks, a considerable burden on patients, especially since many sarcoma patients travel great distances to receive care at specialized sarcoma centers. In this trial, we are testing whether it is safe and effective to deliver preoperative radiation therapy in just 5 treatments over 1 week. A shorter preoperative radiation treatment would significantly reduce the burden on patients.
Adult subjects diagnosed with soft tissue sarcoma, intermediate or high-grade.
For more information about the eligibility criteria for this trial, refer to the Health Professional version.
- Histologically confirmed soft tissue sarcoma of the extremity/trunk
- Intermediate or high grade sarcoma
- Resectable primary lesion (patients with pre-existing metastasis will be included if their primary is still going to be resected)
- Recurrent, any grade, no previous radiation therapy
- Karnofsky performance status (KPS) >= 70 or Eastern Cooperative Oncology Group (ECOG) 0 - 2
- If a woman is of childbearing potential, a negative serum pregnancy test must be documented
- Active treatment of a separate malignancy
- History of prior irradiation to the area to be treated
- Pre-operative chemotherapy (post-op acceptable)