Hypofractionated vs Conventional Fractionated RT in Soft Tissue Sarcomas

NCT05109494 | Recruiting Phase 2 DMC

• 4 other identifiers: 2021-0957Protocol Version 11/21/2024A533300NCI-2021-11388
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Soft Tissue Sarcoma

Keywords

hypofractionated; radiotherapy

Outcome Measures

Primary Outcomes (1)

• Pathologic Necrosis Score on Surgical Pathology Report

  scores range from 0 to 2, lower scores mean there was less dying tissue present

  up to 12 weeks from randomization

Secondary Outcomes (6)

• Incidence of Surgical Margin Status R0, R1, and R2

  up to 12 weeks from randomization

• Incidence of acute wound healing complications up to 120 days after surgery

  up to 6 months from randomization (up to 120 days after surgery)

• Incidence of secondary operation for wound repair

  up to 6 months from randomization (up to 120 days after surgery)

• Incidence of Late Toxicity

  up to 2 years plus or minus 3 months

• Progression Free Survival (PFS)

  up to 5 years

Study Arms (2)

Conventional Fractionated

ACTIVE COMPARATOR

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

Radiation: Conventional Fractionated

Hypofractionated

EXPERIMENTAL

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

Radiation: Hypofractionated

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.

Conventional Fractionated

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

Hypofractionated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant
• Unable to undergo imaging or positioning necessary for radiotherapy planning

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53705, United States

RECRUITING

MeSH Terms

Conditions

Sarcoma

Interventions

Radiation Dose Hypofractionation

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics

Study Officials

• Zachary Morris, MD, PhD

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cancer Connect

CONTACT

800-622-8922; clinicaltrials@cancer.wisc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized by the University of Wisconsin clinical trials team to conventional versus hypofractionated RT. Randomization will be blocked to maintain balance over time, with blocks randomly assigned to sizes of 4 or 6. The randomization will take into account receipt of immunotherapy, to allow for a balance of patients in both arms.

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: November 5, 2021
• Study Start: April 6, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2028
• Last Updated: January 28, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)