Adding Spatially Fractionated Radiation Therapy to Standard Palliative Radiation for Improving Disease-Related Symptoms in Patients With Unresectable Solid Tumors

NCT07856394 | Recruiting DMC

• 3 other identifiers: GMROA2481NCI-2026-0645525-005298
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Response at 1 month - Patient-reported Impression of Change

  Participants rate the most prominent symptom related to the target lesion to be treated on a 7-point scale ranging from -3 (very much worse) to +3 (very much better). Response will be reported as a binary yes/no, defined as a patient reporting that the symptom is moderately better or very much better 1 month after completing treatment.

  Baseline to 1 month follow-up

Secondary Outcomes (3)

• Change in Patient-reported Most Prominent Symptom Intensity

  Baseline to 1 month follow-up

• Response at 3 months - Patient-reported Impression of Change

  At 3 month follow-up

• Radiographic tumor response

  At 3 month follow-up

Study Arms (2)

Group I (SFRT, EBRT)

EXPERIMENTAL

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.

Other: Electronic Health Record Review; Radiation: External Beam Radiation Therapy; Other: Questionnaire Administration; Radiation: Spatially-fractionated Radiation Therapy

Group II (EBRT)

ACTIVE COMPARATOR

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

Other: Electronic Health Record Review; Radiation: External Beam Radiation Therapy; Other: Questionnaire Administration

Interventions

Electronic Health Record Review OTHER

Ancillary studies

Group I (SFRT, EBRT); Group II (EBRT)

External Beam Radiation Therapy RADIATION

Undergo standard palliative EBRT

Also known as: Definitive Radiation Therapy, EBRT, External Beam Radiation, External Beam Radiotherapy, External Beam Radiotherapy (conventional), External Beam RT, external radiation, External Radiation Therapy, external-beam radiation, Radiation, External Beam, Teleradiotherapy, Teletherapy, Teletherapy Radiation

Group I (SFRT, EBRT); Group II (EBRT)

Questionnaire Administration OTHER

Ancillary studies

Group I (SFRT, EBRT); Group II (EBRT)

Spatially-fractionated Radiation Therapy RADIATION

Undergo SFRT

Also known as: GRID Therapy, SFRT, Spatially Fractionated Radiation Therapy

Group I (SFRT, EBRT)

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

NOT YET RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Congresses as Topic; Radiation

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations; Physical Phenomena

Study Officials

• Diego Augusto Santos Toesca, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: October 2, 2026
• Study Start: September 23, 2026
• Primary Completion (Estimated): September 30, 2031
• Study Completion (Estimated): September 30, 2031
• Last Updated: October 2, 2026

Record last verified: 2026-09

Locations

US (2)