NCT05733949

Spatiotemporal Stereotactic Body Radiation Therapy for the Treatment of Patients With Polymetastatic Solid Tumors

A Pilot Study of Spatiotemporal SBRT for Poly-Metastatic Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Metastatic Malignant Solid Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of blood samples
PROCEDURE	Computed Tomography	Undergo CT
RADIATION	Stereotactic Body Radiation Therapy	Undergo ST-SBRT

Timeline

• Start date: 2023-04-27
• Primary completion: 2027-10-11
• Completion: 2027-10-11
• First posted: 2023-02-17
• Last updated: 2025-06-17

Locations

1 site across 1 country: United States