Clinical trial NCT05733949: 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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metastatic Malignant Solid Neoplasm
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-02-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Incidence of adverse events
timeFrame: Within 3 months after the last spatiotemporal stereotactic body radiation therapy (ST-SBRT) fraction
measure: Effectiveness of ST-SBRT
timeFrame: 4 weeks after any ST-SBRT fraction
Secondary outcomes:
measure: Screen failures
timeFrame: Up to 1 year
measure: Number of ST-SBRT fractions received, per subject
timeFrame: Up to 1 year
measure: Number of treatment fractions that require adaptation
timeFrame: Up to 1 year
measure: Percentage of subjects who experience abscopal effect
timeFrame: 4 weeks after any ST-SBRT fraction
measure: Overall survival
timeFrame: Up to 1 year post initiation of study treatment
measure: Change in quality of life
timeFrame: From baseline to 3 months after initial fraction
measure: Change in volume (per lesion)
timeFrame: Baseline through 3 months after the first treatment fraction
measure: Clinical response per fraction (per lesion)
timeFrame: Baseline to after each treatment fraction (each cycle is 28 days)
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Yi-Jen Chen
role: PRINCIPAL_INVESTIGATOR
References: