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Trial Title:
Spatiotemporal Stereotactic Body Radiation Therapy for the Treatment of Patients With Polymetastatic Solid Tumors
NCT ID:
NCT05733949
Condition:
Metastatic Malignant Solid Neoplasm
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo collection of blood samples
Arm group label:
Treatment (ST-SBRT)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT
Arm group label:
Treatment (ST-SBRT)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized Tomography
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Radiation
Intervention name:
Stereotactic Body Radiation Therapy
Description:
Undergo ST-SBRT
Arm group label:
Treatment (ST-SBRT)
Other name:
SABR
Other name:
SBRT
Other name:
Stereotactic Ablative Body Radiation Therapy
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.
Criteria for 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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope Medical Center
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yi-Jen Chen
Phone:
626-218-4589
Email:
yichen@coh.org
Investigator:
Last name:
Yi-Jen Chen
Email:
Principal Investigator
Start date:
April 27, 2023
Completion date:
October 11, 2027
Lead sponsor:
Agency:
City of Hope Medical Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
City of Hope Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05733949
