Trial Title:
Positron Emission Tomography (PET) Guided Stereotactic Body Radiation Therapy for the Treatment of Oligoprogressive Non-small Cell Lung Cancer, Melanoma, and Renal Cell Carcinoma
NCT ID:
NCT05830058
Condition:
Lung Non-Small Cell Carcinoma
Malignant Solid Neoplasm
Melanoma
Renal Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Melanoma
Carcinoma, Renal Cell
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood collection
Arm group label:
ARM I: (standard care SBRT)
Arm group label:
ARM II: (PET guided SBRT)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT or PET/CT
Arm group label:
ARM I: (standard care SBRT)
Arm group label:
ARM II: (PET guided 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:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo PET
Arm group label:
ARM I: (standard care SBRT)
Arm group label:
ARM II: (PET guided SBRT)
Other name:
Medical Imaging, Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Other name:
Positron Emission Tomography Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
Other name:
PT
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
ARM I: (standard care SBRT)
Arm group label:
ARM II: (PET guided SBRT)
Intervention type:
Radiation
Intervention name:
Stereotactic Body Radiation Therapy
Description:
Undergo SBRT
Arm group label:
ARM I: (standard care SBRT)
Arm group label:
ARM II: (PET guided SBRT)
Other name:
SABR
Other name:
SBRT
Other name:
Stereotactic Ablative Body Radiation Therapy
Summary:
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.
Detailed description:
PRIMARY OBJECTIVE:
I. PET adaptive SBRT is both feasible and safe and allows for a higher total dose of
radiation through an inter-fraction simultaneous integrated boost (SIB) based on
inter-fraction PET uptake, leading to improved local control outcomes compared to current
standard SBRT planning without a SIB.
SECONDARY OBJECTIVES:
I. Determine the duration of local and distant control followed PET adaptive SBRT
treatment compared to standard external beam radiation therapy (EBRT).
II. Evaluate the utility of measuring circulating tumor deoxyribonucleic acid (DNA)
(ctDNA) before, during and after SBRT in conjuction with biological imaging to assess
early disease response.
III. Identify genomic predictors to predict for distant progression. IV. Determine
durability of current systemic therapy with SBRT to oligoprogressive sites.
EXPLORATORY OBJECTIVES:
I. Biomarker changes based on ctDNA before, during and after treatment. II. Changes in
fludeoxyglucose (FDG) uptake with SBRT and combined checkpoint inhibitor during and after
treatment and correlation with local and distant control.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo 5 SBRT treatments every other day on study. Patients also undergo
computed tomography (CT) or PET/CT and blood collection throughout study.
ARM II: Patients undergo 3 SBRT treatments every other day week 1, undergo PET/CT and
replanning one month post SBRT, then undergo 2 additional treatments with SIB on study.
Patients also undergo CT or PET/CT and blood collection throughout study.
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
- 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 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
- 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)
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:
Arya Amini
Phone:
626-218-4589
Email:
aamini@coh.org
Investigator:
Last name:
Arya Amini
Email:
Principal Investigator
Start date:
November 29, 2023
Completion date:
January 6, 2026
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/NCT05830058
