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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pathologic Necrosis Score on Surgical Pathology Report
Secondary outcome measures
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
+3 moreTrial 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
Find a Location
Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,189 Previous Clinical Trials
3,169,516 Total Patients Enrolled
Zachary Morris, MD, PhDPrincipal InvestigatorUW School of Medicine and Public Health
2 Previous Clinical Trials
53 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood and kidney tests meet the required levels.I have a confirmed soft tissue sarcoma in my limb, trunk, or head/neck.My doctor agrees that specific targeted radiation therapy is safe and suitable for me before surgery.I am 18 years old or older.I am healthy enough for surgery and can have it within 5-14 days after finishing radiation therapy.I have not received any treatment specifically for sarcoma.I cannot have scans or stay still for radiotherapy planning.I can care for myself but may not be able to do active work.
Research Study Groups:
This trial has the following groups:- Group 1: Conventional Fractionated
- Group 2: Hypofractionated
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the maximum number of participants eligible to enroll in this experiment?
"Affirmative, clinicaltrials.gov indicates that this trial is actively searching for individuals to participate. It was first posted on April 6th 2022 and last updated May 6th 2022, aiming to enroll a total of 30 participants at one site."
Answered by AI
Are there any vacancies left for participants in this research?
"As per the information on clinicaltrials.gov, this trial is currently recruiting patients. This research was initially posted to the website on April 6th 2022 and updated most recently on May 6th 2022."
Answered by AI
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