Vertebral Bone Marrow in Lung Cancer Attention Trial (VMAT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Limited G3L Toxicity
研究概览
简要总结
The purpose of this study is to see whether designing radiation to spare the vertebral bone marrow can limit the rates of lymphopenia during standard of care chemoradiation therapy and in the time to count recovery in the ensuing weeks. Secondary endpoints will examine whether this leads to improved disease control whether this is predictive of improved clinical outcomes such as rates of local recurrence (LR), metastasis free survival (MFS), overall survival (OS), and progression free survival (PFS) which will be followed prospectively up to 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient > 18 years
- •Patients with AJCC (American Joint Committee on Cancer) 8 T1-T4, N1-N3, M0 stage IIIA-IIIC NSCLC (non small cell lung cancer)
- •Patients with oligometastatic disease stage IV, M1 disease, in which definitive concurrent chemoradiotherapy to the thorax is planned
- •CBC/CMP within these limits
- •Absolute lymphocyte count>500/ml
- •Hemoglobin>8 g/dL
- •AST (aspartate aminotransferase)/ALT (alanine transaminase) <2.5 times of ULN
- •Eastern Cooperative Oncology Group (ECOG) 0-2
排除标准
- •History of thoracic irradiation
- •History of palliative radiation for the current malignancy under consideration
- •Patients not being treated with definitive standard of care to the chest
- •History of bone marrow disease and or leukemia
- •History of prior cytotoxic chemotherapy for a disease other than for the current malignancy
- •Polymetastatic disease, defined here as ≥3 or more extrathoracic metastases
- •Administration of concurrent immunotherapy during radiation therapy, either as part of another clinical trial or otherwise
研究组 & 干预措施
Radiation Dose Limitations to VMAT
Patients confirmed to have T1-T3 N1-N3 (Stage IIIA-IIIC) or select Stage IV primary adeno- or squamous cell-carcinoma of the lung will be treated per standard of care; concurrent chemoradiotherapy for 6 to 6.5 weeks, followed by consolidative immunotherapy. A CT simulation scan is obtained with the patient in the treatment position allowing the radiation oncologist to delineate intended tumor targets and organs at risk (OAR). Using specialized treatment planning software, a radiation plan is generated with the goal of maximizing tumor coverage with intended prescription dose and minimizing unintended radiation dose to OARs below established thresholds. The primary intervention of this trial will be sparing the thoracic bone marrow. This will be done by delineating the thoracic bone marrow on the CT simulation scan and applying vertebral marrow-specific OAR constraints during treatment planning to optimally spare radiation dose to this structure during treatment
干预措施: Evidence-based radiation dose limitation to the vertebral bone marrow (Other)
结局指标
主要结局
Limited G3L Toxicity
时间窗: 6 weeks
The primary end point will be evaluating whether implementing dosimetric constraints to the bone marrow will decrease rates of G3L toxicity in the peripheral blood compared to expected rates of 40% in large series examining toxicities during chemoradiation. Values will be expressed as a percentage rates of G3L lymphopenia.
次要结局
- Progression free Survival (PFS)(Baseline to study end (up to 5 years))
- Overall Survival (OS)(Baseline to study end (up to 5 years))
- Change in Neutrophil to Lymphocyte ratio (NLR)(Baseline to study end (up to 5 years))
- Metastasis Free Survival (MFS)(Baseline to study end (up to 5 years))
- Local Recurrence (LR)(Baseline to study end (up to 5 years))