Trial of ctDNA of Guidance to Determine PostOperative Radiation Therapy (PORT) for Minimal Residual Disease (MRD) for Lung Cancer: the MRD-PORT Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Detection of Circulating Tumor DNA (ctDNA) Post-Surgery
研究概览
简要总结
Primary Objective:
Evaluate the role of ctDNA positivity in decision making for postoperative therapy for non-small cell lung cancer. The plan for postoperative therapy will be declared after pathology report review and before the ctDNA result. We will assess if ctDNA result changed the planned therapy.
Secondary Objectives:
Evaluate personalized postoperative Chemo/ICPI/Targeted Therapies/Radiation Therapy in clearing ctDNA Evaluate the disease-free survival (DFS) and overall survival (OS) of stage II/III lung cancer patients with postoperative ctDNA positive status
Exploratory Objective:
Evaluate radiomics features based on serial CT thoracic CT scans to determine if radiomic features can be associated with ctDNA positivity/negativity.
详细描述
This is a pilot, single-arm interventional study evaluating the use of the Haystack™ circulating tumor DNA (ctDNA) assay to guide postoperative radiation therapy (PORT) and systemic therapy decisions for patients with Stage II-III non-small cell lung cancer (NSCLC) who have undergone surgical resection. The study aims to assess whether ctDNA monitoring can effectively detect minimal residual disease (MRD) and improve post-surgical treatment strategies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have provided signed informed consent for the trial
- •Aged ≥18 years at the time of informed consent
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •Diagnosed with histologically confirmed Stage II-III NSCLC and undergone surgical resection of lung tumor
- •No active second cancers/malignancy
- •Patients that received preoperative therapy (including chemotherapy and immunotherapy or others) are eligible
- •Willing and able to comply with all aspects of the protocol
- •Standard of care therapy and methods as per institution and investigator discretion -
排除标准
- •Exclusion Criteria
- •Discontinued treatment due to a Grade 3 or higher AEs with chemotherapy or immunotherapy or targeted therapy agent
- •With a history of another primary malignancy within the past 2 years that is considered an active malignancy by the enrolling physician.
- •Have known active CNS metastases and/or carcinomatous meningitis.
- •Have a history of (non-infectious) pneumonitis that required steroids or have current pneumonitis.
- •Have a history of interstitial lung disease.
- •Have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator. -
研究组 & 干预措施
Single-Arm - ctDNA-Guided Treatment
This single-group interventional arm evaluates the feasibility and impact of ctDNA testing in guiding adjuvant treatment decisions.
干预措施: Haystack™ ctDNA Assay (Diagnostic Test)
结局指标
主要结局
Detection of Circulating Tumor DNA (ctDNA) Post-Surgery
时间窗: Baseline, 2-4 weeks, 3 months, 6 months, and 12 months post-surgery
This outcome will assess the presence or absence of circulating tumor DNA (ctDNA) in blood samples collected at multiple time points following surgical resection of Stage II-III non-small cell lung cancer (NSCLC). The Haystack™ ctDNA assay will be used to detect minimal residual disease (MRD), and results will be evaluated for their ability to predict recurrence and guide postoperative radiation and systemic therapy decisions.
次要结局
- Change in ctDNA Levels Over Time(Baseline, 2-4 weeks, 3 months, 6 months, and 12 months post-surgery)
- Progression-Free Survival (PFS)(Up to 3 years post-surgery)
- Overall Survival (OS)(Up to 5 years post-surgery)
研究者
Salma Jabbour, MD
Professor of Radiation Oncology
Rutgers, The State University of New Jersey