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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I can care for myself but may not be able to do active work.
Select...
I am not planning to have surgery for my condition.
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
Proportion of Participants with 2-year Local Control
Secondary outcome measures
Complete Response Rate
Incidence of Acute Toxicity
Incidence of Long Term Toxicity
+4 moreSide effects data
From 2012 Phase 2 trial • 17 Patients • NCT0098330771%
Rash
53%
Death
41%
Diarrhea
41%
Fatigue
35%
Bilirubin Increased
29%
Nausea
24%
Elevated Hemoglobin
18%
Creatinine increased
18%
Pain
18%
Dyspnea
18%
Dry skin
18%
Esophagitis
18%
Glucose, serum-high
12%
Dyspnea w/ADL
12%
Lymphopenia
12%
Sodium, serum-low
12%
Constipation
12%
Myositis
12%
Dysphagia
12%
Pneumonitis
12%
Anorexia
12%
Dermatitis
12%
Dry eye
12%
Edema
12%
Hypokalemia
12%
Tremor
6%
Blurred vision
6%
Alopecia
6%
Blepharitis
6%
Mucositis
6%
Renal failure
6%
Magnesium
6%
Decreased hearing in left ear
6%
Elevated Glucose
6%
Peripheral neuropathy
6%
Alkaline Phosphatase
6%
Severe pain (back)
6%
Dysgeusia
6%
Dyspepsia
6%
Platelets
6%
Pruritis
6%
Dehydration
6%
Headache
6%
Vomiting
6%
Mucositis/Stomatitis
6%
Hyperkalemia
6%
Muscle weakness, generalized
6%
Dizziness
6%
dysmorphic nail bed
6%
Fever
6%
Elevated Heart Rate
6%
Hypocalcemia
6%
Hyponatremia
6%
Hypoxia
6%
Vaginal Infection
6%
Joint pain
6%
Upper respiratory infection
6%
Vaginal dryness and irritation
6%
White Blood Cells in Urine
6%
Weight loss
6%
Cough
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
1,183 Previous Clinical Trials
3,167,539 Total Patients Enrolled
Zachary Morris, MD, PhDPrincipal InvestigatorUniversity of Wisconsin, Madison
2 Previous Clinical Trials
35 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My soft tissue sarcoma is confirmed by biopsy and cannot be removed by surgery but can be treated with targeted radiotherapy.I haven't had chemotherapy or cancer treatment in the last 2 weeks.I cannot undergo scans or positioning needed for planning radiotherapy.I've had radiation in the same area where doctors now say more radiation isn't safe.I can care for myself but may not be able to do active work.I am not planning to have surgery for my condition.
Research Study Groups:
This trial has the following groups:- Group 1: Hypofractionated Radiotherapy for Soft Tissue Sarcoma
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 the recruitment period for this trial still open?
"Affirmative, the information on clinicaltrials.gov reveals that this medical trial is actively enrolling participants. It was initially posted in June 11th of 2019 and has since been updated September 13th 2022. This research requires 48 individuals from 1 clinic to volunteer their time for participation."
Answered by AI
Has Hypofractionated Radiotherapy received authorization from the FDA?
"Given that Hypofractionated Radiotherapy is in Phase 2 of its clinical trials, our team at Power assessed it as a safety level 2. This indicates that there are some data points supporting its safety but no evidence to support efficacy yet."
Answered by AI
What is the current enrollment for this clinical experiment?
"Affirmative. Clinicaltrials.gov displays that this clinical trial, which was first released on June 11th 2019, is currently seeking participants. 48 individuals need to be recruited from one medical centre."
Answered by AI
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