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RECRUITING

NCT07856394

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

Sponsor: Mayo Clinic

View on ClinicalTrials.gov

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.

Official title: Multicenter, Randomized Phase II Trial on Palliative Radiation With or Without Spatially Fractionated Radiotherapy Boost for Unresectable Bulky Malignancies

Key Details

Gender

All

Age Range

15 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-09-23

Completion Date

2031-09-30

Last Updated

2026-10-07

Healthy Volunteers

Conditions

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

Interventions

OTHER

Electronic Health Record Review

Ancillary studies

RADIATION

External Beam Radiation Therapy

Undergo standard palliative EBRT

OTHER

Questionnaire Administration

Ancillary studies

RADIATION

Spatially-fractionated Radiation Therapy

Undergo SFRT

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

Locations (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States