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About
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.
Full description
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.
Enrollment
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Inclusion criteria
Documented informed consent of the participant and/or legally authorized representative
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
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20 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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