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Radiation

Short-course Radiation Therapy for Sarcoma

N/A

Recruiting

Led By Mitchell Kamrava

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

Histologically confirmed soft tissue sarcoma of the extremity/trunk

Recurrent sarcoma, any grade, no previous radiation therapy

Must not have

Active treatment of a separate malignancy

History of prior irradiation to the area to be treated

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at the side effects of a higher dose of radiation therapy given over a shorter period of time for patients with soft tissue sarcomas.

Who is the study for?

This trial is for adults with a certain type of cancer called soft tissue sarcoma in the limbs or trunk. They should be relatively active and healthy (KPS >= 70 or ECOG 0-2), not pregnant if female, and have a tumor that can be surgically removed. Those with recurring cancer are eligible if they haven't had radiation before; however, people actively treating another cancer or who've had pre-op chemo aren't.

What is being tested?

The study tests hypofractionated radiation therapy given over five days before surgery for soft tissue sarcomas. This approach uses higher doses in fewer sessions compared to traditional radiation, aiming to kill more tumor cells while potentially causing fewer side effects.

What are the potential side effects?

Potential side effects may include skin irritation, fatigue, swelling at the treatment site, and possible damage to nearby tissues or organs due to high-dose radiation exposure. The exact side effects will vary from person to person.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is a type of sarcoma found in my limbs or trunk.

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My sarcoma has come back and I haven't had radiation before.

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I can care for myself and perform normal activities.

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My sarcoma is not low grade.

Exclusion Criteria

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

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I am currently being treated for another cancer.

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I have had radiation therapy on the area that needs treatment now.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

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

Grade >= 2 radiation morbidity (subcutaneous tissue fibrosis, joint stiffness, or edema)

Secondary study objectives

Distant metastasis

Local anesthesia

Overall survival

+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

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)Experimental Treatment4 Interventions

Patients undergo hypofractionated radiation therapy on Monday-Friday for 5 days. Beginning 2-12 weeks after completion of radiation therapy, patients undergo surgery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Conventional Surgery

2006

Completed Phase 3

~1080

Hypofractionated Radiation Therapy

2016

Completed Phase 3

~130