100 Participants NeededMy employer runs this trial

Spatially Fractionated Radiation Therapy for Cancer

Recruiting at 1 trial location
CT
Overseen ByClinical Trials Referral Office
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether spatially fractionated radiation therapy (SFRT) can ease symptoms such as pain, trouble breathing, bleeding, or swallowing difficulties in individuals with inoperable solid tumors. SFRT delivers uneven radiation doses to the tumor, potentially protecting healthy tissue, while the standard method, external beam radiation therapy (EBRT), targets cancer from outside the body. Participants will receive either the standard EBRT alone or both the new SFRT and standard EBRT to determine which approach is more effective. The trial seeks individuals with solid tumors larger than 5 cm who are not surgical candidates and experience significant symptoms like pain or difficulty breathing. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options that might improve quality of life.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, it does allow concurrent systemic therapy (like chemotherapy or immunotherapy) during radiation treatment, so you might be able to continue some treatments. It's best to discuss your specific medications with the trial team.

What prior data suggests that this radiation therapy technique is safe?

Research has shown that spatially fractionated radiation therapy (SFRT) is generally safe and well-tolerated. Studies have found that patients experience few side effects with this treatment. For example, one study noted that SFRT led to a significant reduction in tumor size with only minor side effects. Another report found that about 90% of patients experienced quick and substantial improvements with excellent tolerance to the treatment.

These findings suggest that SFRT is a promising option for those needing relief from symptoms caused by large tumors. By delivering radiation in a grid-like pattern, SFRT aims to protect healthy tissues while targeting the tumor. Overall, evidence supports the safety of SFRT for patients with challenging-to-treat tumors.12345

Why are researchers excited about this trial?

Researchers are excited about Spatially Fractionated Radiation Therapy (SFRT) because it offers a novel approach to treating cancer that differs from traditional methods. SFRT involves delivering high doses of radiation to small, focused areas of the tumor, potentially sparing surrounding healthy tissue more effectively than conventional radiation therapy. This technique could enhance the effectiveness of palliative care by providing immediate relief and possibly improving overall outcomes for patients. Unlike standard External Beam Radiation Therapy (EBRT), which is applied uniformly, SFRT's precision may lead to fewer side effects and a better quality of life for patients during treatment.

What evidence suggests that spatially fractionated radiation therapy is effective for improving symptoms in patients with unresectable solid tumors?

Research has shown that spatially fractionated radiation therapy (SFRT) can effectively treat large tumors. In one study, 84.2% of patients responded positively, with some tumors partially shrinking. Other studies have reported response rates between 78% and 91%, with some tumors disappearing completely. This method uses a grid pattern to focus high doses of radiation on specific tumor parts, potentially protecting nearby healthy tissue. In this trial, participants in Group I will receive a single fraction of SFRT followed by standard palliative external beam radiation therapy (EBRT), while Group II will receive only standard palliative EBRT. Early results suggest that SFRT not only effectively shrinks tumors but also reduces symptoms like pain and breathing problems.12367

Who Is on the Research Team?

DA

Diego Augusto Santos Toesca, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults with solid tumors that cannot be removed by surgery and who need radiation to help relieve symptoms like pain or trouble breathing. People must be able to receive palliative radiation therapy.

Inclusion Criteria

Patients must sign Institutional Review Board (IRB) approved study specific informed consent
Patients must complete all required pre-entry tests within the specified time limits
I am at least 15 years old.
See 6 more

Exclusion Criteria

On a transplant list
Major medical, addictive, or psychiatric illness preventing consent process, treatment completion, or follow-up; consent by legal authorized representative not permitted
I have had radiation to the current tumor site within the last 3 months.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Patients undergo a single fraction of SFRT followed by standard palliative EBRT

1-3 days for SFRT, followed by EBRT as determined by the physician

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months
Follow-up assessments at 1 month and 3 months post-treatment

What Are the Treatments Tested in This Trial?

Interventions

  • External Beam Radiation Therapy
  • Spatially Fractionated Radiation Therapy

Trial Overview

The study compares standard external beam radiation therapy (EBRT) alone versus EBRT combined with spatially fractionated radiation therapy (SFRT), a technique delivering uneven doses of radiation, to see if adding SFRT better relieves cancer-related symptoms.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Group I (SFRT, EBRT)Experimental Treatment4 Interventions
Group II: Group II (EBRT)Active Control3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Citations

Spatially fractionated stereotactic body radiation therapy ...

SFRT, such as GRID, has been used to treat large tumors with reported dramatic tumor response and minimal side effects. SBRT can be difficult to deliver safely ...

Spatially fractionated radiotherapy (Lattice SFRT) in the ...

Among all investigated patients, 16 of 19 (84.2 %) patients achieved an objective response, including 10 individuals achieved a partial ...

Spatially fractionated radiation therapy: History, present and ...

Many reports of patients with large or recurrent tumors treated with GRID therapy showed patients achieving good oncological outcomes … radioresistant tumor is ...

SFRT vs CRT/SBRT

Regarding SFRT technical subtypes, LRT achieved the highest 3-year LCR (81.3%) and lowest. Grade 3+ toxicity (8.5%), followed by proton spatially fractionated ...

Highs and Lows of Spatially Fractionated Radiation Therapy

Median follow-up was 322 days with 1 year overall survival 37% and 1 year local control were highly predictive of local control. Grade 3 ...

Time-Related Outcome Following Palliative Spatially ...

Our findings indicate that ∼90% of symptomatic patients experienced a rapid and substantial benefit. This observation, combined with excellent treatment ...

[A single-center retrospective study on the efficacy and ...

Objectives: To evaluate the safety, short-term efficacy and prognostic characteristics of spatially fractionated radiation therapy (SFRT) in ...