What side effects are associated with this type of intervention?

Common treatments for tumors, such as conventional and altered-fractionation radiation therapy, often result in side effects including fatigue, skin irritation, and localized pain. High-dose radiation treatments, like those used in Spatially Fractionated Radiation (SFR), aim to reduce these side effects by delivering a single high-dose through a grid, which can minimize toxicity and reduce hospital visits. However, potential side effects still include acute reactions like nausea, vomiting, and more severe long-term effects such as fibrosis or secondary malignancies in adjacent tissues.

What prior FDA approvals exist?

The FDA has approved several advanced radiation therapies for the treatment of tumors, focusing on reducing toxicity and improving patient convenience. Techniques such as Stereotactic Radiosurgery (SRS) and Stereotactic Body Radiotherapy (SBRT) deliver high doses of radiation with precision, minimizing damage to surrounding tissues and reducing the number of hospital visits. These methods are particularly beneficial for patients with brain metastases and other localized tumors. Additionally, Intensity-Modulated Radiation Therapy (IMRT) and Proton Beam Therapy have been approved to offer targeted treatment with fewer side effects. These approaches align with the goals of Spatially Fractionated Radiation (SFR) by providing effective tumor control while enhancing patient quality of life.

What other types of research exist?

Promising, novel alternatives to Spatially Fractionated Radiation (SFR) for tumor patients in 2024 include Hypofractionated Radiotherapy, Stereotactic Body Radiotherapy (SBRT), Proton Beam Therapy, and Chemoradiotherapy. These approaches aim to reduce toxicity and the number of hospital visits while maintaining or improving treatment efficacy.

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Radiation Therapy

GRID Therapy for Advanced Cancer

N/A

Recruiting

Led By Te Vuong, MD

Research Sponsored by Sir Mortimer B. Davis - Jewish General Hospital

Eligibility Criteria Checklist

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

Must have

Patient planned to undergo palliative radiation therapy treatments to one of the following 5 sites: extremities, neck, chest, abdomen and pelvis

WHO performance status of 0-2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3, 6, 9, 12 months

Awards & highlights

Study Summary

This trial is testing a new way of giving radiation therapy to people with tumors that are hard to treat. The new method is called spatially fractionated radiation (SFR). It delivers one single treatment through a grid containing holes. The goal of the trial is to see if SFR is a safe and effective way to palliate patients with symptomatic bulky tumors.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While the side effects specific to SFR aren't detailed here, typical side effects from similar palliative radiation therapies may include skin reactions at the treatment site, fatigue, nausea, and potential damage to nearby organs depending on tumor location.

Eligibility Criteria

Inclusion Criteria

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

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

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I can take care of myself and perform light activities.

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I am 18 years old or older.

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My tumor is larger than 8cm, resistant to radiation, or was previously treated with radiation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3, 6, 9, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3, 6, 9, 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, 9, 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Symptom relief, as measured using the CTCAE grading system (v4.0) and pain questionnaire

Secondary outcome measures

Acute toxicity of treatment, as measured using the CTCAE grading system (v4.0)

Cost-effectiveness, as measured by evaluating the cost of the procedure per patient and the efficacy of treatment with regards to symptom relief and tumor response

Long-term toxicity of treatment, as measured using the CTCAE grading system (v4.0)

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: GRID radiation therapyExperimental Treatment1 Intervention

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

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Radiation therapy, including Spatially Fractionated Radiation (SFR), works by damaging the DNA of cancer cells, preventing their replication and causing cell death. SFR delivers a single high-dose of radiation through a grid, focusing on bulky or radioresistant tumors. This approach reduces toxicity, minimizes hospital visits, and improves patient quality of life by sparing healthy tissue while effectively targeting the tumor.

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