This phase II trial studies the effect of hypofractionated radiotherapy followed by surgery in treating patients with soft tissue sarcoma. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving hypofractionated radiotherapy followed by surgery may allow patients with sarcomas to be treated in a much more rapid and convenient fashion.
Additional locations may be listed on ClinicalTrials.gov for NCT04506008.
Locations matching your search criteria
United States
Tennessee
Nashville
Vanderbilt University/Ingram Cancer CenterStatus: Active
Contact: Eric Tatsuo Shinohara
Phone: 615-322-2555
PRIMARY OBJECTIVES:
I. To investigate the efficacy of neoadjuvant hypofractionated radiotherapy (HRT) followed by surgical resection in the treatment of soft tissue sarcoma (STS) as measured by local control (LC).
II. Examine the side effect profile using Radiation Therapy Oncology Group (RTOG) and Common Terminology Criteria for Adverse Events (CTCAE) acute and late side effects criteria and major and minor post-operative complication rates.
OUTLINE: Patients are assigned to 1 of 2 groups by the radiation oncologist.
GROUP I (ULTRA-HYPOFRACTIONATION [UH]): Patients undergo HRT daily for a total of 5 fractions in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.
GROUP II (MODERATE HYPOFRACTIONATION [MH]): Patients undergo HRT daily for a total of 15 fractions in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.
After completion of study treatment, patients are followed up within 3 months, then every 3-6 months for a minimum of 2 years.
Lead OrganizationVanderbilt University/Ingram Cancer Center
Principal InvestigatorEric Tatsuo Shinohara
