This phase II trial tests the safety of positron emission tomography (PET) guided stereotactic body radiation therapy (SBRT) and how well it works to treat non-small cell lung cancer (NSCLC), melanoma, and renal cell carcinoma (RCC) that has up to 5 sites of progression (oligoprogression) compared to standard SBRT. 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. A PET scan is an imaging test that looks at your tissues and organs using a small amount of a radioactive substance. It also checks for cancer and may help find cancer remaining in areas already treated. Using a PET scan for SBRT planning may help increase the dose of radiation given to the most resistant part of the cancer in patients with oligoprogressive NSCLC, melanoma, and RCC.
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
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
Parallel
Biospecimen Collection
Procedure/SurgeryUndergo blood collection
Computed Tomography
Procedure/SurgeryUndergo CT or PET/CT
Positron Emission Tomography
Procedure/SurgeryUndergo PET
Questionnaire Administration
Other interventionAncillary studies
Stereotactic Body Radiation Therapy
RadiationUndergo SBRT
Feasibility and safety of positron emission tomography (PET) adaptive stereotactic body radiation therapy (SBRT)
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.
Time to progression
Defined as time of randomization to disease progression at any site or death. Assessed using the modified Response Evaluation Criteria in Solid Tumors (mRECIST).
Time to next systemic therapy
Overall survival
Quality of life (QOL)
Patient reported outcomes using the Functional Assessment of Cancer Therapy - G. Baseline changes in reported QOL will be summarized. Repeated QOL assessments will be tabulated and graphically displayed to describe the changes of QOL outcomes over time, no formal hypothesis testing is planned. An evaluation by dose, response and other characteristics may also be considered. For quantitative QOL scales, data will be represented using means/ medians, histogram/ boxplots. The area under curve will be used as a summary score for each patient. These can then be averaged across groups for informal assessment. Standard imputation methods will be used to deal with a large proportion of missing data.
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City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
