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PET-Guided SBRT for Oligoprogressive Cancers

This study is testing a new way to deliver stereotactic body radiation therapy (SBRT) for non-small cell lung cancer, melanoma, and renal cell carcinoma that has spread to a few new spots (oligoprogression). SBRT uses precise radiation to target tumors, potentially reducing treatment time and side effects. This trial compares standard SBRT to SBRT guided by positron emission tomography (PET) scans, which help locate cancer. The main goal is to see if PET-guided SBRT is safe and practical, and if it can better control the cancer. You may be able to join if you are 18 or older and have one of these cancers with up to 5 sites of progression. The study aims to enroll 32 participants.

Study design
This is an interventional study where patients are randomly assigned to one of two treatment groups. The study aims to enroll 32 participants.
What's involved
You would undergo 5 SBRT treatments every other day. You will also have blood drawn and receive CT or PET/CT scans throughout the study.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for feasibility and safety is measured at the completion of SBRT up to 5 weeks.

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NCT05830058

Positron Emission Tomography (PET) Guided Stereotactic Body Radiation Therapy for the Treatment of Oligoprogressive Non-small Cell Lung Cancer, Melanoma, and Renal Cell Carcinoma

Recruiting
PHASE2Ages 18+InterventionalTreatment
City of Hope Medical Center
~32 participants
Updated 2026-01-05 on ClinicalTrials.gov
What's tested:Biospecimen CollectionComputed TomographyPositron Emission TomographyQuestionnaire AdministrationStereotactic Body Radiation Therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility and safety of positron emission tomography (PET) adaptive stereotactic body radiation therapy (SBRT)
Measured over At completion of SBRT up to 5 weeks

Conditions

Lung Non-Small Cell Carcinoma
Malignant Solid Neoplasm
Melanoma
Renal Cell Carcinoma

Explore related trials

Lung Non-Small Cell CarcinomaMelanomaRenal Cell CarcinomaSolid Neoplasm

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Arya Amini · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

Who to contact

Arya Amini
[email protected]
626-218-4589
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Documented informed consent of the participant and/or legally authorized representative
Assent, when appropriate, will be obtained per institutional guidelines
Agreement to allow the use of archival tissue from diagnostic tumor biopsies
If unavailable, exceptions may be granted with study principal investigator (PI) approval
Age: \>= 18 years
Eastern Cooperative Oncology Group (ECOG) =\< 2
Histologically or cytologically confirmed NSCLC with 1-5 sites of disease progression while on or following systemic therapy with a checkpoint inhibitor with or without chemotherapy for at least 3 months with radiographic evidence of progression based on Response Evaluation Criteria in Solid Tumors (RECIST) or Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST)
Lesion(s) must all be amenable to SBRT which will be determined by the radiation oncologists. Active lesions should be a minimum size of \>= 1 cm
Primary tumor should be controlled for \> 3 months in the metachronous setting; for synchronouos progression of the primary and oligoprogressive site(s), the primary should be treated with curative/local control intent
Patients eligible for the study must have at least one lesion for which the planned radiation dose achieves a biologic effective dose (BED) \< 100 (alpha/beta = 10) due to organs at risk and dose constraints
If the clinical scenario deem that other forms of local therapy may be more suitable for the metastatic disease, such as surgical resection and interventional radiology-guided ablation, patients would be able to undergo other forms of local therapy after discussion with the study PI but at least one lesion must be treated with SBRT in this scenario
Patients with brain metastases can be included but brain metastases must be treated prior to enrollment and are not considered as a site of oligoprogression
Life expectancy \>= 3 months in the opinion of the treating investigators

Exclusion

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
Unable to undergo a Pet/CT or do not have Pet active disease
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
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)

What this trial measures

  • Feasibility and safety of positron emission tomography (PET) adaptive stereotactic body radiation therapy (SBRT)At completion of SBRT up to 5 weeks

    Feasibility and safety of biologically-guided adaptive planning based on the standardized uptake value (SUV) on pre-treatment and inter-fraction FDG-PET/CT to guide SBRT dose-escalation with a simultaneous integrated boost (SIB) delivered to areas of higher activity in patients with oligoprogressive (1-5 sites) disease when compared to the current standard SBRT planning without inter-fraction adaptive planning, with the goal of demonstrating that PET-adaptive inter-fraction planning can improve total dose delivered over the course of treatment. We will be measuring the difference in total radiation dose in Gy between the two arms with the goal of achieving an absolute dose of 10 Gy or higher.