RightFit
RecruitingPhase 2

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

Phase II Randomized Controlled Trial of Biologically Guided Stereotactic Body Radiation Therapy in Oligoprogressive Non-Small Cell Lung Cancer, Melanoma, and Renal Cell Carcinoma

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: PET scans, CT scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "A PET scan is an imaging test that looks at your tissues and organs using a small amount of a radioactive substance."
  • "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."
  • "Patients also undergo computed tomography (CT) or PET/CT and blood collection throughout study."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares PET scan-guided SBRT with standard SBRT to see how safe it is and how well it works. SBRT is radiation aimed very precisely at tumors. The study description names lung cancer, melanoma skin cancer, and kidney cancer with 1–5 growing cancer sites, but the entry rules specifically list non-small cell lung cancer.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older, agree to join, and allow use of stored tumor samples. The study leader may allow an exception if samples are not available.
  • Be able to care for yourself and be up and about for at least half of your waking hours. Your doctor must expect you to live at least 3 months.
  • Have confirmed non-small cell lung cancer with 1–5 sites shown to be growing on scans, during or after at least 3 months of immune checkpoint treatment, with or without chemotherapy.
  • All growing tumors must be suitable for SBRT and at least 1 centimeter wide.
  • If cancer grows later at other sites, the original tumor must have been controlled for more than 3 months. If both grow at the same time, the original tumor must be treated to cure or control it.
  • At least one tumor must need a planned radiation dose below the study’s set level to protect nearby organs.
  • Other treatments, such as surgery or tumor destruction, may be allowed after discussion with the study leader, but at least one tumor must receive SBRT.
  • Any cancer in the brain must be treated before joining. Brain tumors do not count toward the 1–5 growing sites.

Who can't join

  • The study doctor thinks the study is not suitable for you or you cannot follow its visits, rules, or procedures.
  • A radiation doctor finds that you cannot receive SBRT.
  • You cannot have a PET/CT scan, or your cancer does not show activity on PET scans.
  • You are pregnant or breastfeeding. If you could become pregnant, you must have a negative pregnancy test within 72 hours before treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official 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)

Study sites (2)

CA