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Radiation Therapy

GRID Therapy for Sarcoma

N/A

Recruiting

Led By Theodore K Yanagihara, MD. PhD

Research Sponsored by UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

Age ≥ 18 years at the time of consent.

Eastern Cooperative Oncology Group (ECOG) Performance status of 0 - 2 (Karnofsky Performance Status equivalent of 50 - 100).

Must not have

History of serious or non-healing wound, ulcer, or bone fracture in the treatment limb within the last 5 years.

History of clinically significant lymphedema in the treated limb.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months to 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if GRID radiation therapy can safely increase the radiation dose in patients w/ extremity soft tissue sarcoma, potentially reducing recurrence rate w/o causing more post-op wound complications.

Who is the study for?

This trial is for adults over 18 with extremity soft tissue sarcoma, who can perform daily activities (ECOG status 0-2). They must have a biopsy confirming the diagnosis and agree to study procedures. Excluded are those with prior radiotherapy at the tumor site, complete tumor resection, serious wounds or bone fractures in the limb within 5 years, significant lymphedema, or certain autoimmune diseases.

What is being tested?

The trial tests GRID therapy—a radiation technique that may increase dose without added toxicity—on patients with high-risk sarcoma before standard radiotherapy and surgery. The goal is to see if GRID improves tumor response without increasing wound complications after surgery.

What are the potential side effects?

While specific side effects of GRID therapy will be studied, potential risks may include skin reactions similar to sunburns, fatigue from radiation treatment, and possible delayed wound healing post-surgery due to increased radiation exposure.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I can take care of myself but may not be able to do heavy physical work.

Exclusion Criteria

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

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I have had a serious wound, ulcer, or bone fracture in the last 5 years.

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I have had severe swelling in a limb that was treated.

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I have had radiation therapy on my tumor before.

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My tumor was surgically removed, or it came back after surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months to 6 months 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 or higher post-operative wound complications after GRID-3 months

Secondary study objectives

Grade 2 or higher post-operative wound complications after GRID-6 months

Long Term Safety

The comparative effect of GRID

+1 more

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: Fractionated grid radiation therapyExperimental Treatment1 Intervention

Subjects with resectable extremity soft tissue sarcoma received neoadjuvant grid radiation therapy (GRID), followed by standard-of-care conventional radiotherapy (XRT) and tumor resection.

0 / 6Eligibility criteria met