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Radiation Therapy

Pre-Surgery Hypofractionated Radiation Therapy for Soft Tissue Sarcoma

Phase 2

Waitlist Available

Led By Safia K. Ahmed, M.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No evidence of nodal or distant metastases as determined by clinical examination on any form of imaging

Eastern Cooperative Oncology Group (ECOG) performance status (PS) =< 3

Must not have

Men or women of childbearing potential who are unwilling to employ adequate contraception

Rhabdomyosarcoma, soft tissue osteosarcoma, soft tissue Ewing sarcoma, and benign histologies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at a shorter, higher-dose radiation therapy to see if it decreases wound complications from surgery for patients with localized soft tissue sarcomas.

Who is the study for?

This trial is for adults with a type of cancer called soft tissue sarcoma in the arms, legs, or superficial trunk. It's for those who can have surgery to remove it and haven't had radiation in that area before. Participants need to be able to fill out questionnaires, use birth control if they can have children, and come back for follow-ups.

What is being tested?

The study tests hypofractionated radiation therapy given over fewer days but at higher doses each day before surgery. The goal is to see if this shorter treatment reduces wound problems after surgery compared to traditional longer treatments.

What are the potential side effects?

Potential side effects include skin irritation, fatigue, swelling in treated areas, and more serious risks like damage to nearby organs or tissues due to high-dose radiation exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My scans show no cancer spread to lymph nodes or distant parts of the body.

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I am capable of limited self-care and spend less than half of my day in bed or sitting.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am of childbearing age and not using birth control.

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My cancer is one of the following types: rhabdomyosarcoma, soft tissue osteosarcoma, soft tissue Ewing sarcoma, or it is benign.

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I've had radiation therapy before on the same area where my sarcoma is now.

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My cancer has spread to lymph nodes or other parts of my body.

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I am currently breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 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 patients who experience major wound complications

Secondary study objectives

Change in quality of life - PROMIS-10

Change in quality of life - TESS

Disease

+5 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

Skin hypopigmentation

Edema limbs

Device related infection

100%

80%

60%

40%

20%

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: Treatment (hypofractionated radiation therapy, resection)Experimental Treatment4 Interventions

Patients undergo hypofractionated radiation therapy QD (except weekends and holidays) over 3 weeks for a total of 15 fractions. Within 3-6 weeks after completion of radiation therapy, patients undergo surgical resection.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hypofractionated Radiation Therapy

2016

Completed Phase 3

~130

Resection

2023

Completed Phase 2

~420