Recruiting

SFRT & EBRT

Sponsor:

Mayo Clinic

Code:

NCT07856394

Conditions

Metastatic Malignant Solid Neoplasm

Unresectable Malignant Solid Neoplasm

Eligibility Criteria

Sex: All

Age: 15+

Healthy Volunteers: Not accepted

Interventions

Electronic Health Record Review

External Beam Radiation Therapy

Questionnaire Administration

Spatially-fractionated Radiation Therapy

Study Details

Brief summary:

This clinical trial evaluates whether adding spatially fractionated radiation therapy (SFRT) to standard palliative external beam radiation therapy (EBRT) improves disease-related symptoms in patients with solid tumors that cannot be removed by surgery (unresectable). SFRT, originally termed GRID therapy, is a radiation therapy technique designed to deliver a highly uneven dose of radiation to a tumor. This is achieved by using a grid-like pattern, where isolated regions receive high doses, while the spaces between experience significantly lower doses. This method allows for a greater total dose to be delivered to the tumor while potentially reducing damage to surrounding healthy tissues. EBRT is a type of radiation therapy that uses a machine to aim high-energy rays at the cancer from outside of the body. Adding SFRT to standard palliative EBRT may improve disease-related symptoms such as pain, difficulty breathing, bleeding, or difficulty swallowing in patients with unresectable solid tumors.

Conditions

Metastatic Malignant Solid Neoplasm

Unresectable Malignant Solid Neoplasm

Study ID

NCT07856394

Start date

Sep 23, 2026

Status verified date

Sep, 2026

Completion date

Sep 30, 2031

Anticipated

Primary completion date

Sep 30, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Histologically proven primary or metastatic solid malignant tumors from any histologic subtype
  • Measurable primary or metastatic bulky tumor defined as tumor > 5 cm in largest dimension not eligible for surgical resection or not an ideal candidate for alternative local therapies, e.g., cryoablation, etc.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-3 assessed within 30 days of enrollment
  • Estimated life expectancy > 3 months, as judged by treating clinician
  • 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
  • Patients must be able to start treatment (radiation) within 60 days of study registration
  • Patients must be at least 15 years old
  • A minimum most prominent symptom intensity score reported by the patient of >= 5 on an 11-point symptom intensity scale (item 4.3.2), clearly related to the target lesion, within one the following: pain, dyspnea, hemorrhage, or dysphagia

Exclusion Criteria:

  • Prior RT to the current target site < 3 months from randomization
  • Intracranial invasion by the proposed tumor target or tumor target intertwined with bowel loops
  • Concurrent systemic therapy (e.g., chemotherapy, immunotherapy) during RT delivery will not be an exclusion condition
  • Active rectal diverticulitis, Crohn's disease affecting the rectum, or ulcerative colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are allowed), for patients whose target tumor is in the pelvis
  • Major medical, addictive, or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up. Consent by legal authorized representative is not permitted for this study
  • History of myocardial infarction or decompensated congestive heart failure (CHF) within the last 6 months
  • On a transplant list
  • Any of the following are excluded because this study involves ionizing radiation:

  • Pregnant persons
  • Nursing persons
  • Persons of childbearing potential who are unwilling to employ adequate birth control measures will be asked to stay on adequate forms of birth control until study intervention (therapy) is finished

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group I (SFRT, EBRT)

Patients undergo a single fraction of SFRT. Starting 1-3 days after SFRT, patients undergo standard palliative EBRT in a dose regimen determined by the treating physician.

active comparator: Group II (EBRT)

Patients undergo standard palliative EBRT in a dose regimen determined by the treating physician.

Interventions

Electronic Health Record Review

Ancillary studies

External Beam Radiation Therapy

Undergo standard palliative EBRT

Questionnaire Administration

Ancillary studies

Spatially-fractionated Radiation Therapy

Undergo SFRT

Primary outcome measure

  • Response at 1 month - Patient-reported Impression of Change [ Time Frame: Baseline to 1 month follow-up ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Diego A. Santos Toesca, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Oct 2, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-10-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.