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Radiation Therapy

Hypofractionated Radiotherapy for Soft Tissue Sarcoma

Phase 2
Waitlist Available
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
Karnofsky performance status > 60
Participant refuses surgery or is aware that surgery is not recommended for them
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

Summary

This trial is looking at whether a new way of giving radiation for sarcomas is safe and effective. Currently, the side effects of radiation therapy can be hard on the body, so this study is testing whether a new way of giving the radiation can help reduce those side effects.

Who is the study for?
This trial is for individuals with a confirmed diagnosis of soft tissue sarcoma that can't be removed by surgery or has spread, and who are fit enough to undergo the treatment (Karnofsky performance status > 60). It's not suitable for pregnant individuals, those who've had recent chemotherapy, or anyone unable to have imaging required for planning radiotherapy.
What is being tested?
The study tests Hypofractionated Radiotherapy on soft tissue sarcomas. This approach delivers high doses of radiation in fewer sessions while aiming to minimize damage to surrounding healthy tissues. The goal is better control over tumor growth compared to traditional methods.
What are the potential side effects?
Potential side effects may include skin changes, fatigue, swelling due to fluid buildup, and possible harm to nearby organs depending on the tumor location. Long-term effects could involve fibrosis or secondary cancers but will vary based on individual cases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can care for myself but may not be able to do active work.
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I am not planning to have surgery for my condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot undergo scans or positioning needed for planning radiotherapy.

Timeline

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
Proportion of Participants with 2-year Local Control
Secondary study objectives
Complete Response Rate
Incidence of Acute Toxicity
Incidence of Long Term Toxicity
+4 more

Side effects data

From 2012 Phase 2 trial • 17 Patients • NCT00983307
71%
Rash
53%
Death
41%
Diarrhea
41%
Fatigue
35%
Bilirubin Increased
29%
Nausea
24%
Elevated Hemoglobin
18%
Creatinine increased
18%
Dry skin
18%
Glucose, serum-high
18%
Esophagitis
18%
Dyspnea
18%
Pain
12%
Anorexia
12%
Dry eye
12%
Dysphagia
12%
Edema
12%
Hypokalemia
12%
Tremor
12%
Dyspnea w/ADL
12%
Myositis
12%
Constipation
12%
Pneumonitis
12%
Sodium, serum-low
12%
Lymphopenia
12%
Dermatitis
6%
Headache
6%
Vomiting
6%
Elevated Glucose
6%
Elevated Heart Rate
6%
Hypoxia
6%
Magnesium
6%
Platelets
6%
dysmorphic nail bed
6%
Fever
6%
Blurred vision
6%
Renal failure
6%
Hyperkalemia
6%
Alkaline Phosphatase
6%
Blepharitis
6%
Dyspepsia
6%
Dizziness
6%
Joint pain
6%
Hypocalcemia
6%
Vaginal Infection
6%
White Blood Cells in Urine
6%
Mucositis/Stomatitis
6%
Hyponatremia
6%
Mucositis
6%
Severe pain (back)
6%
Dehydration
6%
Pruritis
6%
Muscle weakness, generalized
6%
Dysgeusia
6%
Alopecia
6%
Decreased hearing in left ear
6%
Peripheral neuropathy
6%
Vaginal dryness and irritation
6%
Cough
6%
Upper respiratory infection
6%
Weight loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Erlotinib and Radiotherapy

Trial Design

1Treatment groups
Experimental Treatment
Group I: Hypofractionated Radiotherapy for Soft Tissue SarcomaExperimental Treatment1 Intervention
Participants will be treated with 3-8 fractions, with the maximum prescribed dose to the Planning Tumor Volume (PTV) volume being 60 Gy delivered over a period of at most 8 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hypofractionated Radiotherapy
2009
Completed Phase 2
~90

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,210 Previous Clinical Trials
3,157,691 Total Patients Enrolled
Zachary Morris, MD, PhDPrincipal InvestigatorUniversity of Wisconsin, Madison
2 Previous Clinical Trials
35 Total Patients Enrolled

Media Library

Hypofractionated Radiotherapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03972930 — Phase 2
Soft Tissue Sarcoma Research Study Groups: Hypofractionated Radiotherapy for Soft Tissue Sarcoma
Soft Tissue Sarcoma Clinical Trial 2023: Hypofractionated Radiotherapy Highlights & Side Effects. Trial Name: NCT03972930 — Phase 2
Hypofractionated Radiotherapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03972930 — Phase 2
~1 spots leftby Dec 2024
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