Hypofractionated vs Conventional Fractionated RT in Soft Tissue Sarcomas
Phase II Trial of Neoadjuvant Hypofractionated Radiotherapy Versus Conventionally Fractionated Radiotherapy for Soft Tissue Sarcomas
University of Wisconsin, Madison
30 participants
Apr 6, 2022
INTERVENTIONAL
Conditions
Summary
This research study is designed to find out if radiation therapy treatment prior to surgery is safe and effective to treat soft tissue sarcomas. 30 participants with soft tissue sarcoma will be enrolled and can expect to be on study for up to 5 years.
Eligibility
Inclusion Criteria9
- Biopsy proven soft tissue sarcoma of the extremity, trunk, or head and neck
- No prior sarcoma-directed chemotherapy or radiotherapy
- Age ≥ 18 years
- Karnofsky performance status ≥ 60
- Able to understand and sign an informed consent
- Life expectancy of greater than 12 weeks
- Hypofractionated or conventionally fractionated radiotherapy using Intensity Modulated Radiation Therapy (IMRT) are both deemed feasible and safe neoadjuvant treatments, at the treating physician's discretion
- Operable disease and medically fit for surgery, based on the opinion of the consulting surgeon; surgery within 5-14 days of completion of radiation therapy (RT)
- Adequate bone marrow function as defined by absolute neutrophil count > 500/mcL, hemoglobin > 8 g/dL, platelets > 50,000/mcL; adequate renal function as defined by creatinine clearance > 30 mL/min
Exclusion Criteria2
- Pregnant
- Unable to undergo imaging or positioning necessary for radiotherapy planning
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Interventions
50 Gy in 25 fractions will be prescribed to cover 95% of the planning tumor volume (PTV). More than 99% of the PTV should receive \> 97% of the prescribed dose. For dose homogeneity, no more than 20% of the PTV will receive ≥ 110% prescription dose.
27.5 Gy in 5 fractions will be prescribed to cover 95% of the PTV. More than 99% of the PTV should receive \> 97% of the prescribed dose
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05109494