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Radiation

Hypofractionated Radiation Therapy for Soft Tissue Sarcoma

Phase 2

Waitlist Available

Led By Beverly A Guadagnolo

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 3 or less

Tumor located in the soft tissues of the extremities or superficial trunk

Must not have

Previous radiation therapy to the site of the sarcoma or area surrounding it such that it would be encompassed by the radiation field needed to treat the current sarcoma. In other words, treatment on this trial would require re-irradiation of tissues

Women who are pregnant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 120 days after radiation therapy

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at the risk of wound complications from shorter, more convenient radiation therapy for patients with localized soft tissue sarcoma.

Who is the study for?

This trial is for adults with localized soft tissue sarcoma in limbs or superficial trunk, who can undergo surgery and have no distant cancer spread. They must be able to follow up, use contraception if capable of childbearing, and have a life expectancy over 6 months. Those previously treated with radiation at the same site or pregnant women are excluded.

What is being tested?

The study tests a shorter course of high-dose radiation therapy before surgery compared to traditional longer courses. It aims to see if this approach reduces tumor cells effectively while causing fewer side effects and complications during wound healing.

What are the potential side effects?

Potential side effects may include skin irritation, fatigue, swelling in treated areas, and possible delayed wound healing due to the higher doses of radiation given over a short time frame.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself but can't do heavy physical work.

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My tumor is in the soft tissue of my limbs or upper body.

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My cancer has not spread to lymph nodes or other parts of my body.

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My cancer is a type of sarcoma that started in my soft tissues.

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My sarcoma can be fully removed by surgery.

Exclusion Criteria

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

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

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I am currently pregnant.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 120 days after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 120 days after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 120 days after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to a major wound complication (MWC)

Secondary study objectives

Disease free survival (DFS) time

Disease specific survival time

Functional outcomes

+4 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 RT)Experimental Treatment3 Interventions

Patients receive hypofractionated radiation therapy in 15 daily fractions over 3 weeks in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hypofractionated Radiation Therapy

2016

Completed Phase 3

~130

0 / 8Eligibility criteria met