GRID Therapy for Advanced Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Sir Mortimer B. Davis - Jewish General Hospital
Disqualifiers: Curable cancer, Previous hypofractionation, Spinal/brain tumor, Pregnant/nursing
No Placebo Group
Approved in 3 Jurisdictions
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.
12345Is 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.
45678How 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.
13456Eligibility 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.
+3 more
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
+1 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: GRID radiation therapyExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Sir Mortimer Jewish General HospitalMontreal, Canada
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Who Is Running the Clinical Trial?
Sir Mortimer B. Davis - Jewish General HospitalLead Sponsor
References
Early clinical results of proton spatially fractionated GRID radiation therapy (SFGRT). [2022]Approximately 70 patients with large and bulky tumors refractory to prior treatments were treated with photon spatially fractionated GRID radiation (SFGRT). We identified 10 additional patients who clinically needed GRID but could not be treated with photons due to adjacent critical organs. We developed a proton SFGRT technique, and we report treatment of these 10 patients.
Dosimetric Validation for Prospective Clinical Trial of GRID Collimator-Based Spatially Fractionated Radiation Therapy: Dose Metrics Consistency and Heterogeneous Pattern Reproducibility. [2023]Dose heterogeneity within a tumor target is likely responsible for the biologic effects and local tumor control from spatially fractionated radiation therapy (SFRT). This study used a commercially available GRID-pattern dose mudulated nonuniform radiation therapy (GRID) collimator to assess the interplan variability of heterogeneity dose metrics in patients with various bulky tumor sizes and depths.
Spatially fractionated (GRID) therapy for large and bulky tumors. [2018]Avanced bulky tumors warrant aggressive therapy to attempt to maximize local control of the disease. Spatially fractionated radiation therapy (GRID) delivers a single-fraction of high dose radiation to these tumors with a curative or palliative goal. GRID therapy may be combined with fractionated radiation therapy or used in a therapeutic multi-modality setting to achieve control of the bulky disease. Current clinical data confirms the value of GRID therapy in the management of large volume of disease with an acceptable toxicity profile. GRID therapy has broad systemic effects leading to increases in a variety of cytokines that correlate with clinical outcome.
Photon GRID Radiation Therapy: A Physics and Dosimetry White Paper from the Radiosurgery Society (RSS) GRID/LATTICE, Microbeam and FLASH Radiotherapy Working Group. [2021]The limits of radiation tolerance, which often deter the use of large doses, have been a major challenge to the treatment of bulky primary and metastatic cancers. A novel technique using spatial modulation of megavoltage therapy beams, commonly referred to as spatially fractionated radiation therapy (SFRT) (e.g., GRID radiation therapy), which purposefully maintains a high degree of dose heterogeneity across the treated tumor volume, has shown promise in clinical studies as a method to improve treatment response of advanced, bulky tumors. Compared to conventional uniform-dose radiotherapy, the complexities of megavoltage GRID therapy include its highly heterogeneous dose distribution, very high prescription doses, and the overall lack of experience among physicists and clinicians. Since only a few centers have used GRID radiation therapy in the clinic, wide and effective use of this technique has been hindered. To date, the mechanisms underlying the observed high tumor response and low toxicity are still not well understood. To advance SFRT technology and planning, the Physics Working Group of the Radiosurgery Society (RSS) GRID/Lattice, Microbeam and Flash Radiotherapy Working Groups, was established after an RSS-NCI Workshop. One of the goals of the Physics Working Group was to develop consensus recommendations to standardize dose prescription, treatment planning approach, response modeling and dose reporting in GRID therapy. The objective of this report is to present the results of the Physics Working Group's consensus that includes recommendations on GRID therapy as an SFRT technology, field dosimetric properties, techniques for generating GRID fields, the GRID therapy planning methods, documentation metrics and clinical practice recommendations. Such understanding is essential for clinical patient care, effective comparisons of outcome results, and for the design of rigorous clinical trials in the area of SFRT. The results of well-conducted GRID radiation therapy studies have the potential to advance the clinical management of bulky and advanced tumors by providing improved treatment response, and to further develop our current radiobiology models and parameters of radiation therapy design.
Effective spatially fractionated GRID radiation treatment planning for a passive grid block. [2022]To commission a grid block for spatially fractionated grid radiation therapy (SFGRT) treatments and describe its clinical implementation and verification through the record and verify (R&V) system.
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]Spatially fractionated radiotherapy (GRID) has been utilized primarily in the palliative and definitive treatment of bulky tumors. Delivered in the modern era primarily with megavoltage photon therapy, this technique offers the promise of safe dose escalation with potential immunogenic, bystander and microvasculature effects that can augment a conventionally fractionated course of radiotherapy. At the University of Maryland, an institutional standard has arisen to incorporate a single fraction of GRID radiation in large (>8 cm), high-risk soft tissue and osteosarcomas prior to a standard fractionated course. Herein, we report on the excellent pathologic responses and apparent safety of this regimen in 26 consecutive patients.
2D mapping of radiation dose and clonogenic survival for accurate assessment ofin vitroX-ray GRID irradiation effects. [2023]Spatially fractionated radiation therapy (SFRT or GRID) is an approach to deliver high local radiation doses in an 'on-off' pattern. To better appraise the radiobiological effects from GRID, a framework to link local radiation dose to clonogenic survival needs to be developed. A549 lung cancer cells were irradiated in T25 cm2flasks using 220 kV x-rays with an open field or through a tungsten GRID collimator with periodical 5 mm openings and 10 mm blockings. Delivered nominal doses were 2, 5, and 10 Gy. A novel approach for image segmentation was used to locate the centroid of surviving colonies in scanned images of the cell flasks. GafchromicTMfilm dosimetry (GFD) and FLUKA Monte Carlo (MC) simulations were employed to map the dose at each surviving colony centroid. Fitting the linear-quadratic (LQ) function to clonogenic survival data for open field irradiation, the expected survival level at a given dose level was calculated. The expected survival levels were then mapped together with the observed levels in the GRID-irradiated flasks. GFD and FLUKA MC gave similar dose distributions, with a mean peak-to-valley dose ratio of about 5. LQ-parameters for open field irradiation gaveα=0.24±0.02Gy-1andβ=0.019±0.002Gy-2. The mean relative percentage deviation between observed and predicted survival in the (peak; valley) dose regions was (4.6; 3.1) %, (26.6; -1.0) %, and (129.8; -2.3) % for 2, 5 and 10 Gy, respectively. In conclusion, a framework for mapping of surviving colonies following GRID irradiation together with predicted survival levels from homogeneous irradiation was presented. For the given cell line, our findings indicate that GRID irradiation causes reduced survival in the peak regions compared to an open field configuration.
A Dose Accumulation Assessment of Alignment Errors During Spatially Fractionated Radiation Therapy. [2023]Spatially fractionated radiotherapy (SFRT) techniques produce high-dose peaks and low-dose valleys within a tumor. Lattice stereotactic body radiation therapy (SBRT) is a form a SFRT delivered across five fractions. Due to the high spatial dose gradients associated with SFRT, it is critical for fractionated SFRT patients to be aligned correctly for treatment. Here we investigate the dosimetric impact of daily alignment uncertainty through a dose accumulation study.