Using PET scans to guide targeted radiation therapy for certain cancers
Phase II Randomized Controlled Trial of Biologically Guided Stereotactic Body Radiation Therapy in Oligoprogressive Non-Small Cell Lung Cancer, Melanoma, and Renal Cell Carcinoma
This study is testing if using PET scans to guide targeted radiation therapy can help people with certain cancers, like lung cancer and melanoma, get better results than standard treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Duarte, California) |
| Trial ID | NCT05830058 on ClinicalTrials.gov |
What this trial studies
This phase II trial evaluates the safety and effectiveness of positron emission tomography (PET) guided stereotactic body radiation therapy (SBRT) for treating oligoprogressive non-small cell lung cancer, melanoma, and renal cell carcinoma. The study compares this innovative approach to standard SBRT, aiming to deliver higher doses of radiation to resistant tumor areas while minimizing damage to surrounding healthy tissue. Patients will be randomized into two groups, receiving different SBRT treatment regimens, and their responses will be monitored through imaging and blood tests. The trial also explores the potential of circulating tumor DNA as a biomarker for treatment response.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with oligoprogressive non-small cell lung cancer, melanoma, or renal cell carcinoma who have 1-5 sites of disease progression.
Not a fit: Patients with uncontrolled primary tumors or those who do not meet the specific eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved local control of tumors and better overall outcomes for patients with oligoprogressive cancers.
How similar studies have performed: Other studies have shown promise with similar PET-guided approaches, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Duarte, California
- City of Hope Medical Center — Duarte, California, United States (Recruiting)
Study contacts
- Principal investigator: Arya Amini — City of Hope Medical Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.