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Radiation Therapy

Hypofractionated Radiation Therapy for Soft Tissue Sarcoma

N/A

Waitlist Available

Led By Meena Bedi, MD

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

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

Must have

Karnofsky Performance Status (KPS) 60 or above

No prior radiotherapy to primary site or adjacent site that results in overlapping radiation fields.

Must not have

Patients who have metastatic disease

Patients with a history of metastatic disease from a primary other than sarcoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if a new way of giving radiation to people with a certain kind of cancer is feasible, has minimal side effects, and helps control the cancer.

Who is the study for?

This trial is for adults over 18 with Stage I-III Soft Tissue Sarcoma in the limbs or chest-wall, without metastatic disease. Participants must be medically operable, have a performance status score of 60 or above, and not have had prior radiotherapy where fields overlap. Pregnant women and those unable to undergo MRI are excluded.

What is being tested?

The study tests hypofractionated preoperative radiation therapy's safety and effectiveness on local tumor control and survival rates in patients with localized soft tissue sarcomas. It's a Phase II pilot trial that isn't randomized.

What are the potential side effects?

Potential side effects may include skin changes, fatigue, swelling at the treatment site, pain or discomfort during treatment sessions. Long-term effects can vary but might involve changes to bone or muscle tissue.

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 need occasional help.

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I haven't had radiation therapy on or near the primary cancer site.

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I have had a core needle biopsy.

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My sarcoma is in an arm or leg and hasn't spread to other body parts.

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My cancer is a confirmed soft tissue sarcoma in my arm, leg, or chest-wall.

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I am 18 years old or older.

Exclusion Criteria

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

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My cancer has spread to other parts of my body.

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I have had cancer spread from a different type than sarcoma.

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My soft tissue sarcoma is not in my limbs or chest wall.

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My cancer is not a type of sarcoma.

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My tumor is at least 20 cm in size.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

Local Disease Control Assessed by Magnetic Resonance Imaging (MRI)

Local Disease Control Assessed by Physical Examination

Secondary study objectives

Disease-free Survival

Musculoskeletal Tumor Rating Scale (MSTS) Score

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: Hypofractionated Radiation TherapyExperimental Treatment1 Intervention

Radiation treatment in which the total dose of radiation is divided into large doses and treatments are given every other day. Hypofractionated radiation therapy is given over a shorter period of time (fewer days or weeks) than standard radiation therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hypofractionated Radiation Therapy

2016

Completed Phase 3

~130

0 / 11Eligibility criteria met