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Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas: Expansion Cohort

About

Brief Summary

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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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.

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Active treatment of a separate malignancy
  • History of prior irradiation to the area to be treated
  • Pre-operative chemotherapy (post-op acceptable)

Join this Trial

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Study Stats
Protocol No.
15-001657
Category
Oncology
Radiation Oncology
Contact
Jackie Hernandez
Location
  • UCLA Porter Ranch
  • UCLA Westwood
For Providers
NCT No.
NCT02701153
For detailed technical eligibility, visit ClinicalTrials.gov.