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Spots Global Cancer Trial Database for Spatiotemporal Stereotactic Body Radiation Therapy for the Treatment of Patients With Polymetastatic Solid Tumors

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Trial Identification

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

Official Title: A Pilot Study of Spatiotemporal SBRT for Poly-Metastatic Cancer

Study ID: NCT05733949

Study Description

Brief 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

City of Hope Medical Center, Duarte, California, United States

Contact Details

Name: Yi-Jen Chen

Affiliation: City of Hope Medical Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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