The Impact of Radiation Therapy doses on Cardiac Toxicity and Survival in Thoracic Malignancies - An Ambispective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- To identify the high-risk cohort of patients for cardiac toxicity in patients treated with Radiotherapy ± Chemotherapy for thoracic malignancies
研究概览
简要总结
Radiotherapy is employed in the management of various thoracic malignancies, such as those affecting the lung, esophagus, and thymus. Due to the proximity of these tumors to the heart, there is increased risk of cardiac complications, which depend upon a variety of factors including patient age, cardiac history, comorbidities, radiation dose and concurrent chemotherapy regimens. The primary objective of this study is to evaluate the occurrence of cardiac side effects in patients subjected to radiotherapy for thoracic malignancies. Our observational study aims to assess potential correlations between these cardiac complications and clinical, imaging, and laboratory parameters. Additionally, we seek to ascertain the predictive value of dose-related factors in anticipating the likelihood of cardiac sequelae in such patients.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Pathological or cytological evidence of malignancy
- •Patients treated with thoracic radiotherapy ± chemotherapy (neoadjuvant, adjuvant, and definitive radiation)
- •Patients willing to sign the written informed consent
- •Patients willing for follow up.
排除标准
- •Age <18 years
- •Reirradiation to the thoracic area where cardiac structures already received a significant dose
- •Life expectancy of less than 6 months.
结局指标
主要结局
To identify the high-risk cohort of patients for cardiac toxicity in patients treated with Radiotherapy ± Chemotherapy for thoracic malignancies
时间窗: Baseline, 6 months, 12 months and yearly thereafter
AND
时间窗: Baseline, 6 months, 12 months and yearly thereafter
To evaluate any grade cardiac toxicities in thoracic cancer patients treated with definitive Radiotherapy ± Chemotherapy
时间窗: Baseline, 6 months, 12 months and yearly thereafter
次要结局
- Cumulative Incidence of ≥ Grade 3 Cardiac Toxicity(6 months, 12 months and yearly thereafter)
- To assess the impact of dosimetric parameters of the whole heart and its substructures(6 months, 12 months and yearly thereafter)
- Correlation of Cardiac Biomarkers with Cardiac Toxicity and Survival in Severely high-risk patients(6 months, 12 months and yearly thereafter)
- To identify radiological and functional imaging correlates of cardiac toxicity(6 months, 12 months and yearly thereafter)
- Number of patients requiring Cardiac Intervention(6 months, 12 months and yearly thereafter)
研究者
Anil Tibdewal
Tata Memorial Hospital