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

Primary Purpose

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

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Biospecimen Collection
Computed Tomography
Positron Emission Tomography
Questionnaire Administration
Stereotactic Body Radiation Therapy
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Non-Small Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • City of Hope Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ARM I: (standard care SBRT)

ARM II: (PET guided SBRT)

Arm Description

Patients undergo 5 SBRT treatments every other day on study. Patients also undergo 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Incidence of adverse events
Clinician documented toxicity using common terminology for adverse events version 5.
Local control rates
Assessed using the mRECIST.
Dose delivered
Defined as the dose delivered in the experimental group for the first 3 fractions versus the dose given for the last 2 fractions.

Full Information

First Posted
March 17, 2023
Last Updated
October 6, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05830058
Brief 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
Official Title
Phase II Randomized Controlled Trial of Biologically Guided Stereotactic Body Radiation Therapy in Oligoprogressive Non-Small Cell Lung Cancer, Melanoma, and Renal Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 19, 2023 (Anticipated)
Primary Completion Date
January 6, 2026 (Anticipated)
Study Completion Date
January 6, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Non-Small Cell Carcinoma, Malignant Solid Neoplasm, Melanoma, Renal Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ARM I: (standard care SBRT)
Arm Type
Experimental
Arm Description
Patients undergo 5 SBRT treatments every other day on study. Patients also undergo CT or PET/CT and blood collection throughout study.
Arm Title
ARM II: (PET guided SBRT)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Biospecimen Collection
Other Intervention Name(s)
Biological Sample Collection, Biospecimen Collected, Specimen Collection
Intervention Description
Undergo blood collection
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography
Intervention Description
Undergo CT or PET/CT
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT
Intervention Description
Undergo PET
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiation Therapy
Other Intervention Name(s)
SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Intervention Description
Undergo SBRT
Primary Outcome Measure Information:
Title
Feasibility and safety of positron emission tomography (PET) adaptive stereotactic body radiation therapy (SBRT)
Description
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 Frame
At completion of SBRT up to 5 weeks
Secondary Outcome Measure Information:
Title
Time to progression
Description
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 Frame
Up to 12 months
Title
Time to next systemic therapy
Time Frame
Up to 12 months
Title
Overall survival
Time Frame
Up to 12 months
Title
Quality of life (QOL)
Description
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.
Time Frame
Up to 12 months
Title
Incidence of adverse events
Description
Clinician documented toxicity using common terminology for adverse events version 5.
Time Frame
At 3, 6, and 12 months following radiation therapy
Title
Local control rates
Description
Assessed using the mRECIST.
Time Frame
Up to 12 months
Title
Dose delivered
Description
Defined as the dose delivered in the experimental group for the first 3 fractions versus the dose given for the last 2 fractions.
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arya Amini
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arya Amini
Phone
626-218-4589
Email
aamini@coh.org
First Name & Middle Initial & Last Name & Degree
Arya Amini

12. IPD Sharing Statement

Learn more about this trial

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

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