RecruitingPhase 2NCT05109494

Hypofractionated vs Conventional Fractionated RT in Soft Tissue Sarcomas

Phase II Trial of Neoadjuvant Hypofractionated Radiotherapy Versus Conventionally Fractionated Radiotherapy for Soft Tissue Sarcomas


Sponsor

University of Wisconsin, Madison

Enrollment

30 participants

Start Date

Apr 6, 2022

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two radiation schedules before surgery for people with soft tissue sarcoma (a cancer of connective tissues like muscle or fat): a shorter, more concentrated dose versus a longer, conventional course of radiation. **You may be eligible if...** - You have biopsy-confirmed soft tissue sarcoma of the arm, leg, trunk, or head and neck - You have not previously received chemotherapy or radiation for this sarcoma - You are 18 years or older and in reasonably good health (Karnofsky score ≥60%) - Your tumor is operable and you are medically fit for surgery - Surgery can be planned within 5–14 days after completing radiation **You may NOT be eligible if...** - You have previously received radiation or chemotherapy for your sarcoma - Your tumor cannot be surgically removed - Your general health is too poor to safely undergo surgery - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONConventional Fractionated

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.

RADIATIONHypofractionated

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)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

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NCT05109494


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