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

Trial Summary

What is the purpose of this trial?

This trial is testing a new radiation technique called Spatially Fractionated Radiation (SFR) for patients with large or hard-to-treat tumors. SFR aims to reduce side effects and hospital visits by delivering a single treatment through a special grid. This method has been used to deliver a single high-dose treatment to large areas, reducing overall side effects.

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 data supports the effectiveness of the treatment GRID Therapy for Advanced Cancer?

Research shows that GRID therapy, which delivers high-dose radiation in a unique pattern, has been effective in managing large and bulky tumors, improving treatment response with acceptable side effects. It has shown promise in clinical studies for advanced tumors, with broad effects that may enhance outcomes. ^{1 2 3 4 5}

Is GRID Therapy safe for humans?

GRID Therapy, also known as Spatially Fractionated Radiation Therapy (SFRT), has shown promising safety results in clinical studies, particularly for treating large tumors. Research from the University of Maryland reported apparent safety in 26 patients with high-risk soft tissue and bone cancers, suggesting it can be safely combined with standard radiation treatments. ^{4 5 6 7 8}

How is GRID Therapy different from other treatments for advanced cancer?

GRID Therapy is unique because it uses a technique called spatially fractionated radiation therapy (SFRT), which delivers high doses of radiation in a non-uniform pattern to target large, bulky tumors. This approach allows for higher doses with potentially less damage to surrounding healthy tissue, and it may enhance the immune response against the tumor. ^{1 3 4 5 6}

Research Team

Te Vuong, MD

Principal Investigator

Sir Mortimer Jewish General Hospital

Eligibility Criteria

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.

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

Pregnant or nursing woman

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Early clinical results of proton spatially fractionated GRID radiation therapy (SFGRT). [2022]

2. United States 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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Spatially fractionated (GRID) therapy for large and bulky tumors. [2018]

4. United States 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. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Effective spatially fractionated GRID radiation treatment planning for a passive grid block. [2022]

6. United States 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. [2021]

7. England pubmed.ncbi.nlm.nih.gov

2D mapping of radiation dose and clonogenic survival for accurate assessment ofin vitroX-ray GRID irradiation effects. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

A Dose Accumulation Assessment of Alignment Errors During Spatially Fractionated Radiation Therapy. [2023]