GRID Therapy for Advanced Cancer

Overseen By Luciana Poggi, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sir Mortimer B. Davis - Jewish General Hospital

Disqualifiers: Curable cancer, Previous hypofractionation, Spinal/brain tumor, Pregnant/nursing

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of delivering radiation therapy called Spatially Fractionated Radiation (SFR) for individuals with advanced cancer. The researchers aim to determine if SFR can safely and effectively reduce symptoms from large or hard-to-treat tumors by delivering a single dose of radiation through a grid. This approach may suit those with tumors larger than 8 cm or tumors that typically resist regular radiation, such as melanoma or sarcoma. Participants must have cancer in areas like the extremities, neck, chest, abdomen, or pelvis. As an unphased trial, this study provides patients the opportunity to explore innovative treatment options that might not be available elsewhere.

Do I have to stop taking my current medications for the trial?

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

What prior data suggests that Spatially Fractionated Radiation Therapy is safe for palliative treatment of advanced cancer?

Studies have shown that Spatially Fractionated Radiation Therapy (SFRT) is generally safe and effective for treating large and difficult tumors. Reports highlight low levels of toxicity in patients, resulting in fewer side effects. Many patients also experienced significant tumor shrinkage and symptom relief. This technique has been used successfully even in patients with prior radiation treatments.

Research indicates that SFRT can be delivered safely and quickly, making it a promising option for those with advanced cancer. Overall, the therapy is well-tolerated, enabling patients to manage their conditions with less time spent in the hospital. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about GRID radiation therapy for advanced cancer because it offers a unique approach to radiation treatment. Unlike standard radiation therapies, which typically deliver a uniform dose across the entire tumor, GRID therapy uses spatially fractionated radiation. This means it delivers high doses of radiation in a grid-like pattern, allowing for a higher dose to be concentrated in specific areas while sparing surrounding healthy tissue. This method has the potential to enhance the effectiveness of treatment while minimizing side effects, making it a promising option for patients with advanced cancer.

What evidence suggests that Spatially Fractionated Radiation Therapy is effective for advanced cancer?

This trial will evaluate the effectiveness of spatially fractionated radiation therapy (SFRT), also known as GRID therapy, for treating large, hard-to-treat tumors. Research has shown that SFRT can be very effective, providing high rates of symptom relief and significantly reducing tumor size. Some patients even experience long-term tumor control and survival. Reports indicate that SFRT is safe and causes less harm than traditional radiation methods. This treatment uses alternating high and low doses of radiation to target the tumor more precisely. Overall, SFRT offers promising results for managing large and advanced tumors. ^{1 3 4 6 7}

Who Is on the Research Team?

Te Vuong, MD

Principal Investigator

Sir Mortimer Jewish General Hospital

Are You a Good Fit for This Trial?

This trial is for adults aged 18+ with confirmed malignancies, who have bulky tumors larger than 8cm or tumors resistant to radiation like melanoma. It's also for those previously treated with palliative radiation needing more than one fraction. Patients must be able to consent and have a WHO performance status of 0-2. Pregnant women, patients with brain/spinal cord tumors, previous hypofractionated radiation therapy, or curable conditions are excluded.

Inclusion Criteria

Ability to sign and understand an informed consent form

I am scheduled for radiation therapy on my limbs, neck, chest, abdomen, or pelvis for symptom relief.

I can take care of myself and perform light activities.

Exclusion Criteria

I have had radiation therapy aimed at easing symptoms.

Pregnant or nursing woman

My tumor is near the spinal cord or in the brain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive a single dose of 15-20 Gys of spatially fractionated radiation therapy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after radiation treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Spatially Fractionated Radiation Therapy

Trial Overview The trial tests spatially fractionated radiation therapy (SFR) as a single-session treatment through a grid for symptomatic bulky or radioresistant tumors. The goal is to validate SFR's safety and effectiveness compared to traditional multiple-session palliative treatments that can cause significant toxicity.

How Is the Trial Designed?

Group I: GRID radiation therapy Experimental Treatment 1 Intervention

A single dose of 15-20Gys of spatially fractionated radiation therapy

Spatially Fractionated Radiation Therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Grid Therapy for:

• Palliative treatment for advanced and symptomatic tumors
• Bulky or radioresistant tumors

Approved in European Union as Spatially Fractionated Radiation Therapy for:

• Palliative treatment for advanced and symptomatic tumors
• Bulky or radioresistant tumors

Approved in Canada as SFRT for:

• Palliative treatment for advanced and symptomatic tumors
• Bulky or radioresistant tumors

Who Is Running the Clinical Trial?

Sir Mortimer B. Davis - Jewish General Hospital

Lead Sponsor

Trials

61

Recruited

25,800+

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]

The study of 14 bulky tumors treated with GRID collimator-based spatially fractionated radiation therapy (SFRT) showed consistent dose distribution metrics, indicating reliable delivery of radiation across different tumor sizes and depths.

The GRID therapy demonstrated a stable high dose core density and uniform doses for both radiosensitive and radioresistant cancer cells, suggesting its potential effectiveness and reproducibility for clinical applications in radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric Validation for Prospective Clinical Trial of GRID Collimator-Based Spatially Fractionated Radiation Therapy: Dose Metrics Consistency and Heterogeneous Pattern Reproducibility. Zhang, H., Ma, L., Lim, A., 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]

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]

The study developed a framework to link local radiation doses to the survival of A549 lung cancer cells, showing that spatially fractionated radiation therapy (GRID) results in reduced cell survival in peak dose regions compared to traditional open field irradiation.

Using advanced dosimetry techniques, the research found that the dose distribution from GRID irradiation was consistent, with a peak-to-valley dose ratio of about 5, indicating a significant difference in the effectiveness of radiation delivery in different areas of the treatment field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

2D mapping of radiation dose and clonogenic survival for accurate assessment ofin vitroX-ray GRID irradiation effects. Arous, D., Lie, JL., Håland, BV., et al.[2023]

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]

In a study involving 10 patients undergoing lattice stereotactic body radiation therapy (SBRT), daily alignment errors averaged 1.8 mm, leading to only minor changes in the dose distribution within the tumor, with a slight decrease in the dose ratio from 3.42 to 3.32.

However, larger alignment errors of more than 5 mm significantly impacted the dosimetric outcomes, particularly in high-dose areas, with the worst-case scenario showing a decrease in the dose ratio to 2.72, indicating the importance of precise patient alignment for effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Dose Accumulation Assessment of Alignment Errors During Spatially Fractionated Radiation Therapy. Ginn, J., Duriseti, S., Mazur, T., et al.[2023]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12055688/

Progress of the application of spatially fractionated radiation ... SFRT has shown high symptom remission rates, significant target volume reduction, and even tumor control and long-term survival in some cases ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2452109425001447

A Phase 1 Proton Spatially Fractionated Radiation Therapy ... Spatial fractionation (SFRT) is a radiation therapy technique that targets bulky tumors by delivering alternating high and low doses within the tumor.

3. redjournal.org redjournal.org/article/S0360-3016(25)00383-9/fulltext

Reported Early Clinical Outcomes of Forward-Planned ... Same-day 3‐dimensional MLC-based SFRT method provides fast, safe, and effective management of large, bulky, unresectable tumors for both ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12512144/

Spatially fractionated radiotherapy for re-irradiation SFRT is a safe, feasible, and effective technique for re-irradiation. Patients were re-treated with 66.7 Gy in 5 fractions to a high-dose ...

5. advancesradonc.org advancesradonc.org/article/S2452-1094(23)00136-7/fulltext

Practice Patterns of Spatially Fractionated Radiation Therapy 1. Clinical series of SFRT reported markedly high tumor responses and low toxicity in challenging bulky and advanced tumors.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2405630825001417

Spatially fractionated radiotherapy for re-irradiation SFRT is a safe, feasible, and effective technique for re-irradiation · Patients were re-treated with 66.7 Gy in 5 fractions to a high-dose vertex ...

7. 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 ...