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.
Eligibility Criteria
Age Range: 15 years to No maximum
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