spatiotemporal stereotactic body radiation therapy for the treatment of patients with polymetastatic solid tumors

Conditions: Metastatic Malignant Solid Neoplasm

Summary: this clinical trial evaluates the safety and effectiveness of spatiotemporal stereotactic body radiation therapy (st-sbrt) in treating patients with solid tumors that have spread to other parts of the body (polymetastatic). sbrt uses special equipment to position a patient and deliver radiation to tumors with high precision. this method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. st-sbrt is designed to deliver radiation directly to the core of the tumor, while keeping the radiation exposure of the area around the tumor at minimal dosage.

primary objective: i. to conduct a first evaluation of the toxicity and efficacy of st-sbrt, targeting polymetastatic lesions as small as 2.0 cm. secondary objectives: i. to describe feasibility using: ia. percentage of patients with screen failure; ib. number of st-sbrt fractions given per subject; ic. percentage of treatment fractions that require adaptation. ii. to summarize: iia. percentage of subjects with clinical response in non-irradiated lesions (abscopal effect); iib. duration of earliest clinical response; iic. frequency of late toxicity; iid. 1-year overall survival; iie. 3-month change in total tumor volume; iif. 3-month change in quality of life per functional assessment of cancer therapy (fact)-general (g). iii. to evaluate whether a lesion's irradiation status is associated with its change in volume after 4 weeks. iv. to compare alternate guidelines (immune-modified response evaluation criteria in solid tumors \[irecist\], immune-related response evaluation criteria in solid tumors \[irrecist\], positron emission tomography \[pet\] response criteria in solid tumors \[percist\]) against response evaluation criteria in solid tumors (recist) version (v)1.1 for ability to detect clinical response in irradiated and non-irradiated lesions. v. to evaluate whether, at 3 months after first treatment fraction, the net change in total tumor volume is associated with net change in quality of life (fact-g). exploratory objective: i. to identify serologic markers correlated with net change in lesion volume. outline: patients undergo st-sbrt on study. patients also undergo collection of blood samples at screening and on study and undergo computed tomography (ct) at screening, on study, and during follow up.

Eligibility criteria:
inclusion criteria: * documented informed consent of the participant and/or legally authorized representative * assent, when appropriate, will be obtained per institutional guidelines * age: \>= 18 years * karnofsky performance status \> 60 * poly-metastatic disease, \> 5 lesions, and with at least one lesion \> 2.0 cm, with limited treatment options, and ineligible for or in progression under the standard systemic therapy * pre-screening assessment confirms that the intervention can be administered without exceeding dose constraint guidelines * patients with brain metastases can be included but brain metastases must be treated prior to enrollment and follow up magnetic resonance imaging (mri) 3 months after treatment shows stable findings * spinal cord metastases are allowed as long as treatment with or without radiation is completed * prior radiotherapy in general is allowed, as long as the composite plan meets dose constraints * life expectancy \>= 3 months in the opinion of the treating investigators * off systemic therapy for at least one month prior and one month after study intervention exclusion criteria: * judgement by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions, and requirements * those not eligible for sbrt after review by a radiation oncologist * serous medical comorbidities precluding radiotherapy * unable to undergo a ct scan * pregnant and/or breastfeeding women are excluded from this study as these agents may have the potential for teratogenic or abortifacient effects. female patients of childbearing potentially must have a negative urine or serum pregnancy test within 72 hours prior to receiving therapy * on active systemic therapy * prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)