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

Last updated: December 29, 2024
Sponsor: City of Hope Medical Center
Overall Status: Active - Recruiting

Phase

2

Condition

Cancer/tumors

Melanoma

Renal Cell Carcinoma

Treatment

Questionnaire Administration

Positron Emission Tomography

Computed Tomography

Clinical Study ID

NCT05830058
22350
NCI-2023-02155
P30CA033572
22350
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Documented informed consent of the participant and/or legally authorizedrepresentative

  • 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 diseaseprogression while on or following systemic therapy with a checkpoint inhibitor withor without chemotherapy for at least 3 months with radiographic evidence ofprogression based on Response Evaluation Criteria in Solid Tumors (RECIST) orPositron Emission Tomography Response Criteria in Solid Tumors (PERCIST)

  • Lesion(s) must all be amenable to SBRT which will be determined by the radiationoncologists. Active lesions should be a minimum size of >= 1 cm

  • Primary tumor should be controlled for > 3 months in the metachronous setting; forsynchronouos progression of the primary and oligoprogressive site(s), the primaryshould be treated with curative/local control intent

  • Patients eligible for the study must have at least one lesion for which the plannedradiation dose achieves a biologic effective dose (BED) < 100 (alpha/beta = 10) dueto organs at risk and dose constraints

  • If the clinical scenario deem that other forms of local therapy may be more suitablefor the metastatic disease, such as surgical resection and interventionalradiology-guided ablation, patients would be able to undergo other forms of localtherapy after discussion with the study PI but at least one lesion must be treatedwith SBRT in this scenario

  • Patients with brain metastases can be included but brain metastases must be treatedprior to enrollment and are not considered as a site of oligoprogression

  • Life expectancy >= 3 months in the opinion of the treating investigators

Exclusion

Exclusion Criteria:

  • Judgement by the investigator that the patient is unsuitable to participate in thestudy and the patient is unlikely to comply with study procedures, restrictions, andrequirements

  • 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 mayhave the potential for teratogenic or abortifacient effects. Female patients ofchildbearing 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 tocomply with all study procedures (including compliance issues related tofeasibility/logistics)

Study Design

Total Participants: 32
Treatment Group(s): 5
Primary Treatment: Questionnaire Administration
Phase: 2
Study Start date:
November 29, 2023
Estimated Completion Date:
February 03, 2027

Study 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.

Connect with a study center

  • City of Hope Medical Center

    Duarte, California 91010
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.