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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

No Placebo-Only Group

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:

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I cannot undergo scans or positioning needed for planning radiotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Headache

Vomiting

Elevated Glucose

Elevated Heart Rate

Hypoxia

Magnesium

Platelets

dysmorphic nail bed

Fever

Blurred vision

Renal failure

Hyperkalemia

Alkaline Phosphatase

Blepharitis

Dyspepsia

Dizziness

Joint pain

Hypocalcemia

Vaginal Infection

White Blood Cells in Urine

Mucositis/Stomatitis

Hyponatremia

Mucositis

Severe pain (back)

Dehydration

Pruritis

Muscle weakness, generalized

Dysgeusia

Alopecia

Decreased hearing in left ear

Peripheral neuropathy

Vaginal dryness and irritation

Cough

Upper respiratory infection

Weight loss

100%

80%

60%

40%

20%

Study treatment Arm

Erlotinib and Radiotherapy

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 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

0 / 3Eligibility criteria met