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

Официальное название

A Pilot Study of Spatiotemporal SBRT for Poly-Metastatic Cancer

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Biospecimen Collection
  Undergo collection of blood samples
• Процедура Computed Tomography
  Undergo CT
• Лучевая терапия Stereotactic Body Radiation Therapy
  Undergo ST-SBRT

Первичные конечные точки

• Incidence of adverse events [Срок оценки: Within 3 months after the last spatiotemporal stereotactic body radiation therapy (ST-SBRT) fraction]
• Effectiveness of ST-SBRT [Срок оценки: 4 weeks after any ST-SBRT fraction]

Вторичные конечные точки (8)

• Screen failures [Срок оценки: Up to 1 year]
• Number of ST-SBRT fractions received, per subject [Срок оценки: Up to 1 year]
• Number of treatment fractions that require adaptation [Срок оценки: Up to 1 year]
• Percentage of subjects who experience abscopal effect [Срок оценки: 4 weeks after any ST-SBRT fraction]
• Overall survival [Срок оценки: Up to 1 year post initiation of study treatment]
• Change in quality of life [Срок оценки: From baseline to 3 months after initial fraction]
• Change in volume (per lesion) [Срок оценки: Baseline through 3 months after the first treatment fraction]
• Clinical response per fraction (per lesion) [Срок оценки: Baseline to after each treatment fraction (each cycle is 28 days)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• City of Hope Medical Center — Duarte

Идентификаторы

NCT: NCT05733949 · 22277 · NCI-2023-00245 · 22277 · P30CA033572

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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