Phase II Randomized Controlled Trial of Biologically Guided Stereotactic Body Radiation Therapy in Oligoprogressive Non-Small Cell Lung Cancer, Melanoma, and Renal Cell Carcinoma
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Lung Non-Small Cell Carcinoma
- 发起方
- City of Hope Medical Center
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Feasibility and safety of positron emission tomography (PET) adaptive stereotactic body radiation therapy (SBRT)
- 状态
- 招募中
- 最后更新
- 3个月前
概览
简要总结
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.
详细描述
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.
研究者
入排标准
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Feasibility and safety of positron emission tomography (PET) adaptive stereotactic body radiation therapy (SBRT)
时间窗: At completion of SBRT up to 5 weeks
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.
次要结局
- Dose delivered(Up to 12 months)
- Time to next systemic therapy(Up to 12 months)
- Quality of life (QOL)(Up to 12 months)
- Incidence of adverse events(At 3, 6, and 12 months following radiation therapy)
- Local control rates(Up to 12 months)
- Time to progression(Up to 12 months)
- Overall survival(Up to 12 months)