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Radiation Therapy

Hypofractionated vs Conventional Radiation Therapy for Soft Tissue Sarcoma

Phase 2

Recruiting

Led By Zachary Morris, MD, PhD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Biopsy proven soft tissue sarcoma of the extremity, trunk, or head and neck

Must not have

Unable to undergo imaging or positioning necessary for radiotherapy planning

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if radiation therapy before surgery is a safe and effective treatment for soft tissue sarcomas. Up to 30 people with the cancer will be enrolled and followed for up to 5 years.

Who is the study for?

This trial is for adults over 18 with soft tissue sarcoma who haven't had previous treatments, are fit for surgery, and have good organ function. They must be able to undergo radiation therapy planning and sign consent. Pregnant individuals or those unable to undergo necessary imaging are excluded.

What is being tested?

The study compares two types of pre-surgery radiation therapies: conventional fractionated (standard approach) versus hypofractionated (fewer, higher-dose treatments). It aims to determine the safety and effectiveness of these methods in treating soft tissue sarcomas.

What are the potential side effects?

Radiation therapy may cause skin irritation at the treatment site, fatigue, nausea, changes in appetite, swelling or stiffness in treated areas. Long-term effects can include more serious complications depending on individual patient factors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My blood and kidney tests meet the required levels.

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I have a confirmed soft tissue sarcoma in my limb, trunk, or head/neck.

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I am 18 years old or older.

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I have not received any treatment specifically for sarcoma.

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I can care for myself but may not be able to do active work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot have scans or stay still for radiotherapy planning.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pathologic Necrosis Score on Surgical Pathology Report

Secondary study objectives

Incidence of Late Toxicity

Incidence of Surgical Margin Status R0, R1, and R2

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

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: HypofractionatedExperimental Treatment1 Intervention

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

Group II: Conventional FractionatedActive Control1 Intervention

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

0 / 6Eligibility criteria met