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.
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
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
Parallel
Electronic Health Record Review
Other interventionAncillary studies
External Beam Radiation Therapy
RadiationUndergo standard palliative EBRT
Questionnaire Administration
Other interventionAncillary studies
Spatially-fractionated Radiation Therapy
RadiationUndergo SFRT
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.
Change in Patient-reported Most Prominent Symptom Intensity
Participants will record the severity of the most prominent symptom related to the target lesion (e.g., pain, dyspnea, hemorrhage, dysphagia) using an 11-point Likert scale ranging from 0 (none) to 10 (unbearable). A between-group comparison of the magnitude of the severity scores will be made.
Response at 3 months - 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 3 months after completing treatment.
Radiographic tumor response
Radiographic tumor response at 3 months post-treatment will be assessed by a modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Radiographic tumor response will be coded as a 1 if the patient meets the complete response (CR) or partial response (PR) modified RECIST criteria and 0 otherwise. Per the modified RECIST criteria, CR will be defined as disappearance of the target lesion, PR will be defined as ≥30% decrease in longest diameter (LD) of target lesion as compared to baseline measurement, Progressive Disease (PD) will be defined as ≥20% increase in LD of target lesion as compared to baseline measurement, and Stable Disease (SD) will be defined as not meeting the criteria for CR, PR, or PD.
Click on the lead sponsor to view all of their trials.
