GRID Therapy for Sarcoma

Overseen By Erin Jennings

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: UNC Lineberger Comprehensive Cancer Center

Disqualifiers: Prior radiotherapy, Tumor resection, Non-healing wound, Lymphedema, Lupus, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a special type of radiation called GRID therapy for individuals with extremity soft tissue sarcoma, a cancer that grows in tissues such as muscles and tendons in the arms or legs. The goal is to determine if GRID therapy can shrink tumors before surgery without increasing side effects. The trial seeks participants with a confirmed diagnosis of extremity soft tissue sarcoma who have not yet undergone radiation or complete tumor removal. As an unphased trial, this study provides patients the opportunity to contribute to innovative research that could lead to new treatment options.

Do I need to stop my current medications for the GRID Therapy trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that GRID therapy is safe for patients with extremity soft tissue sarcoma?

Research has shown that GRID therapy can be a safe option for treating sarcomas. This method uses high doses of radiation to target tumors while minimizing harm to healthy tissue. One study found that patients with difficult-to-treat sarcomas tolerated GRID therapy well, without a significant increase in side effects. Another study described the treatment as both innovative and practical, focusing on reducing side effects. Although formal studies remain limited, early results are promising and suggest that GRID therapy can be safely used for sarcomas. ^{1 2 3 4 5}

Why are researchers excited about this trial?

GRID Therapy is unique because it uses a targeted radiation approach that differs from the typical wide-field radiation used in treating sarcoma. Unlike traditional therapies, which often affect a broader area, GRID Therapy delivers radiation in a patterned, grid-like fashion. This method aims to concentrate the treatment's impact on the tumor while sparing more healthy tissue, potentially reducing side effects. Researchers are excited about this approach because it may enhance the effectiveness of standard radiotherapy and improve surgical outcomes by shrinking tumors more effectively before removal.

What evidence suggests that GRID therapy is effective for soft tissue sarcoma?

Studies have shown that GRID therapy effectively treats large, hard-to-remove soft tissue sarcomas. Research indicates that it targets tumors with high doses of radiation while minimizing damage to nearby healthy tissue. Early findings suggest that GRID therapy can shrink tumors that usually resist radiation. In this trial, participants will receive GRID therapy followed by standard-of-care conventional radiotherapy. Combining GRID therapy with regular radiation treatments has successfully produced strong responses in sarcoma cases. Overall, GRID therapy shows promise in improving tumor response without causing additional side effects. ^{1 2 3 4 6}

Who Is on the Research Team?

Theodore K Yanagihara, MD. PhD

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Written informed consent was obtained to participate in the study and HIPAA authorization for the release of personal health information. Subjects are willing and able to comply with study procedures based on the judgment of the investigator.

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

My diagnosis of soft tissue sarcoma was confirmed through a biopsy.

Exclusion Criteria

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

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

I have a condition like lupus or Ehlers-Danlos that might react badly to radiation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

GRID Radiation Therapy

A single priming dose of GRID radiation therapy is administered to subjects with high-risk extremity soft tissue sarcoma

1 week

Standard Radiotherapy and Tumor Resection

Participants receive standard-of-care conventional radiotherapy followed by tumor resection

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of post-operative wound complications

6 months

What Are the Treatments Tested in This Trial?

Interventions

• GRID Therapy

Trial Overview 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.

How Is the Trial Designed?

Group I: Fractionated grid radiation therapy Experimental Treatment 1 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.

GRID Therapy is already approved in United States for the following indications:

Approved in United States as GRID Therapy for:

• Extremity Soft Tissue Sarcoma

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

Radiation Oncology Institute

Collaborator

Trials

3

Recruited

30+

Published Research Related to This Trial

Proton spatially fractionated GRID radiation (SFGRT) was successfully used to treat 10 patients with large tumors that could not be treated with photon GRID due to critical organ proximity, showing an 80% rate of tumor regression or local symptom improvement.

The treatment was well-tolerated, with 50% of patients experiencing only mild acute side effects, indicating that proton SFGRT is a feasible and effective alternative for patients who cannot receive photon-based treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early clinical results of proton spatially fractionated GRID radiation therapy (SFGRT). Mohiuddin, M., Lynch, C., Gao, M., et al.[2022]

Spatially fractionated radiotherapy (GRID) has shown promising results in treating large, high-risk tumors, particularly soft tissue and osteosarcomas, by allowing for safe dose escalation and enhancing the effects of conventional radiotherapy.

In a study of 26 patients, incorporating a single fraction of GRID radiation before standard treatment resulted in excellent pathologic responses and demonstrated an apparent safety profile, suggesting its potential as an effective treatment strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spatially Fractionated Radiotherapy (GRID) Prior to Standard Neoadjuvant Conventionally Fractionated Radiotherapy for Bulky, High-Risk Soft Tissue and Osteosarcomas: Feasibility, Safety, and Promising Pathologic Response Rates. Snider, JW., Molitoris, J., Shyu, S., et al.[2021]

The study developed novel mini-GRID radiation therapy methods that achieved high peak-to-valley ratios, indicating a potential for more targeted treatment while sparing healthy tissue, with ratios significantly higher than those reported for conventional methods.

In a pre-clinical mouse study, both GRID therapy and hemi-irradiation effectively delayed tumor growth compared to controls, but neither was as effective as traditional whole-tumor irradiation, suggesting that while promising, GRID therapy may need to be combined with other treatments to enhance its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An investigation of kV mini-GRID spatially fractionated radiation therapy: dosimetry and preclinical trial. Johnson, TR., Bassil, AM., Williams, NT., et al.[2023]

Spatially fractionated radiation therapy (GRID) effectively targets advanced bulky tumors with high doses in a single treatment, aiming for either curative or palliative outcomes.

Clinical data shows that GRID therapy not only helps manage large tumors with an acceptable level of toxicity but also induces systemic effects that increase cytokines associated with better clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spatially fractionated (GRID) therapy for large and bulky tumors. Peñagarícano, JA., Griffin, R., Corry, P., et al.[2018]

The study successfully implemented a grid block for spatially fractionated grid radiation therapy (SFGRT), demonstrating that it can effectively treat bulky tumors with a significant reduction in treatment time compared to traditional methods, improving patient throughput.

Dosimetric measurements showed that the grid block technique has clinically acceptable accuracy, with discrepancies in dose calculations being minimal (less than 4% in the build-up region and less than 2% at deeper levels), supporting its safe and effective use in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective spatially fractionated GRID radiation treatment planning for a passive grid block. Nobah, A., Mohiuddin, M., Devic, S., et al.[2022]

Spatially fractionated radiation therapy (SFRT), such as GRID radiation therapy, shows promise in improving treatment responses for bulky primary and metastatic cancers by using a highly heterogeneous dose distribution, which allows for higher prescription doses than conventional radiotherapy.

The Physics Working Group of the Radiosurgery Society has developed consensus recommendations to standardize GRID therapy practices, which is crucial for enhancing clinical outcomes and facilitating rigorous clinical trials in this innovative treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photon GRID Radiation Therapy: A Physics and Dosimetry White Paper from the Radiosurgery Society (RSS) GRID/LATTICE, Microbeam and FLASH Radiotherapy Working Group. Zhang, H., Wu, X., Zhang, X., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10943518/

Spatially Fractionated Radiation Therapy in Sarcomas We analyzed clinical and treatment outcomes in patients with bone and soft tissue sarcomas treated with modern SFRT techniques. Methods and ...

2. redjournal.org redjournal.org/article/S0360-3016(09)02242-1/fulltext

Spatially Fractionated Grid Radiation (SFGRT): A Novel ... Conclusions. The combined use of SFGRT and external beam radiation is an effective way for treating large recurrent and unresectable soft tissue sarcomas.

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-08687

Spatially Fractionated GRID Radiation Therapy for the ... Early results with this method have shown that GRID therapy reduces the effects of radiation on normal tissue while delivering high doses of radiation to areas ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06980259

Spatially Fractionated Radiotherapy Versus Conventional ... This study is a multicenter, prospective, randomized controlled phase II clinical trial designed to evaluate the efficacy and safety of Spatially Fractionated ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4277376/

Effective spatially fractionated GRID radiation treatment ... Clinical experience using megavoltage SFGRT indicates that dramatic tumour responses can be produced even in tumours with intrinsic resistance to radiation, ...

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/448301

GRID Therapy for Extremity Soft Tissue Sarcoma This single-arm pilot study will assess the safety of spatially fractionated grid radiation therapy (GRID) on 20 subjects with resectable ...