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

Sponsor: Mayo Clinic • ClinicalTrials.gov ID: NCT07856394

Registry updated: 2026-10-07

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Description

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.

Interventions

Electronic Health Record Review (Other)
Ancillary studies
External Beam Radiation Therapy (Radiation)
Undergo standard palliative EBRT
Questionnaire Administration (Other)
Ancillary studies
Spatially-fractionated Radiation Therapy (Radiation)
Undergo SFRT

Eligibility criteria

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

Conditions

Metastatic Malignant Solid Neoplasm Unresectable Malignant Solid Neoplasm Unresectable Solid Tumor Malignant Tumor Metastatic Solid Tumor

Locations

Mayo Clinic in Arizona — Scottsdale, Arizona, United States
Mayo Clinic in Rochester — Rochester, Minnesota, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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