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Radiation
Short-course Radiotherapy for Soft Tissue Sarcoma
N/A
Recruiting
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is investigating if a 5-day radiotherapy could be used to treat soft tissue sarcoma and if it has fewer complications than traditional treatment.
Who is the study for?
Adults over 18 with stage I-III soft tissue sarcoma in limbs or trunk, fit for surgery and radiotherapy. Excluded if they have cancer spread to distant parts of the body, previous radiation in the same area, are treating another cancer simultaneously, or plan to use chemotherapy before/after surgery.Check my eligibility
What is being tested?
The trial tests a short-term (5-day) pre-surgery radiotherapy approach for soft tissue sarcoma patients. It aims to see how well this method works compared to traditional longer treatments by looking at tumor response, healing complications, control of local tumor growth and side effects within one year.See study design
What are the potential side effects?
Potential side effects include skin changes like redness and irritation where treated; fatigue; swelling; pain; wound healing issues post-surgery; and other acute reactions that may occur shortly after treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of 5-day HFRT
Secondary outcome measures
1-year late HFRT toxicity
Acute toxicity
Local Control
+2 moreOther outcome measures
Assessing patient rated importance of short course of radiotherapy in decision to participate in study
Comparison of retention rate for radiotherapy at the clinical site
Comparison of serum SFRP2 levels before and after preoperative 5-Day HFRT
+2 moreSide effects data
From 2022 Phase 2 trial • 107 Patients • NCT0332480280%
Dermatitis radiation
54%
Skin hyperpigmentation
48%
Pain
35%
Lymphedema
22%
Superficial soft tissue fibrosis
7%
Skin hypopigmentation
6%
Edema limbs
2%
Device related infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 1 (Radiation Therapy, 15 Fractions)
Arm 2 (Hypofractionated Radiation Therapy, 5 Fractions)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Hypofractionated Radiation TherapyExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hypofractionated Radiation Therapy
2016
Completed Phase 2
~130
Find a Location
Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
933 Previous Clinical Trials
7,394,621 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is in an early to mid-stage and is located in my limbs or torso.I am over 18 years old.I am scheduled for chemotherapy before or after surgery.I am considered a good candidate for a type of surgery that removes only the cancerous area.I am not receiving treatment for another cancer.I have had radiation therapy in the area to be treated.I am eligible for radiotherapy based on screening.I can care for myself but may not be able to do heavy physical work.My cancer has spread to distant parts of my body.
Research Study Groups:
This trial has the following groups:- Group 1: Hypofractionated Radiation Therapy
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.
Is enrollment open for this experiment?
"According to the clinicaltrials.gov database, this particular study is not currently actively recruiting research participants. Initially posted on May 1st 2023 and last updated 8th March of the same year; however, there are 450 other medical trials continuing enrollment at present time."
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