Hypofractionated vs Conventional Fractionated RT in Soft Tissue Sarcomas

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT05109494
Phase
PHASE2
Status
Recruiting
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Conditions

  • Soft Tissue Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Conventional Fractionated — RADIATION
    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.
  • Hypofractionated — RADIATION
    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

Study Details

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.

Key Dates

Start date
Apr 6, 2022
Status verified
Dec 2025
Primary completion
Nov 30, 2026
Completion
Nov 30, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Conventional Fractionated
    radiation treatments will be delivered daily, delivered over a maximum of 7 weeks from the first treatment, surgery will be within 5-14 days of completion of RT
  • Experimental: Hypofractionated
    the maximum frequency of treatment will be every day and the minimum frequency will be every other day, delivered over a maximum of 3 weeks from the first treatment, surgery will be within 5-14 days of completion of RT

Primary Outcome Measure

Pathologic Necrosis Score on Surgical Pathology Report [ Time Frame: up to 12 weeks from randomization ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Wisconsin Hospital and ClinicsMadisonWisconsin53705
Cancer Connect
[email protected]
800-622-8922

Find similar trials in Madison, WI

By research site
University of Wisconsin Hospital and Clinics· Madison, WI

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