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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
No Placebo-Only Group

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.
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.
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 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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
Feasibility of 5-day HFRT
Secondary study objectives
1-year late HFRT toxicity
Acute toxicity
Local Control
+2 more
Other study objectives
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 more

Side effects data

From 2023 Phase 3 trial • 107 Patients • NCT03324802
80%
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)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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 3
~130

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
973 Previous Clinical Trials
7,399,369 Total Patients Enrolled

Media Library

Hypofractionated Radiation Therapy (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT05776667 — N/A
Soft Tissue Sarcoma Research Study Groups: Hypofractionated Radiation Therapy
Soft Tissue Sarcoma Clinical Trial 2023: Hypofractionated Radiation Therapy Highlights & Side Effects. Trial Name: NCT05776667 — N/A
Hypofractionated Radiation Therapy (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05776667 — N/A
~1 spots leftby Dec 2024
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