Hypofractionated vs Conventional Fractionated RT in Soft Tissue Sarcomas
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.
Conditions:
🦠 Soft Tissue Sarcoma
🗓️ Study Start (Actual) 6 April 2022
🗓️ Primary Completion (Estimated) November 2026
✅ Study Completion (Estimated) November 2026
👥 Enrollment (Estimated) 30
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Madison, Wisconsin, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Biopsy proven soft tissue sarcoma of the extremity, trunk, or head and neck
    • * No prior sarcoma-directed therapy
    • * 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 Criteria:

    • * Pregnant
    • * Unable to undergo imaging or positioning necessary for radiotherapy planning
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 14 October 2021
  • First Submitted that Met QC Criteria 3 November 2021
  • First Posted 5 November 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 13 May 2024
  • Last Update Posted 16 May 2024
  • Last Verified May 2024