Neoadjuvant Therapy for Locally Advanced Esophageal Cancer: Impact on Cardiopulmonary Physiology, Short- and Long-term Morbidity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 384
- 试验地点
- 2
- 主要终点
- Change in FEV1 following administration of neoadjuvant chemotherapy versus chemoradiation
研究概览
简要总结
Although recent global trends indicate reduced postoperative mortality after esophagectomy, major morbidity, in particular pulmonary, remains high, with considerable health and economic costs. In a recent modern international collaborative series of 2704 patients from high-volume centers, with an approximate equal mix of open and minimally invasive approaches, respiratory complications were evident in 28% of patients, pneumonia in 15%, and respiratory failure in 7%.1 In other series, respiratory failure is reported in up to 15% of patients and is the most common cause of mortality. Prediction of risk and prevention of respiratory morbidity is therefore of considerable importance, and in this context baseline assessment of respiratory physiology compliments clinical assessment, history and enhanced recovery pathways representing key elements of current patient management.
In this study, which will include all prospective patients with locally advanced esophageal cancer treated at a National Center, pulmonary function will be systematically measured before and after neoadjuvant therapy. The investigators seek to evaluate the incidence of radiation induced lung injury (RILI), as well as subclinical changes in pulmonary physiology that may be linked to postoperative complications, and quality-of-life in survivorship, and to compare cohorts who received radiation therapy or chemotherapy alone, preoperatively.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Locally advanced esophageal cancer undergoing multimodal therapy with curative intent at study centre during study period
- •Pulmonary function assessed at a minimum of one preoperative timepoint
排除标准
- •Salvage, palliative or emergency surgery
结局指标
主要结局
Change in FEV1 following administration of neoadjuvant chemotherapy versus chemoradiation
时间窗: 4-6 weeks post completion of neoadjuvant therapy
Changes in FEV1 (forced expiratory volume in one second, litres), both as a raw value, and as percentage of predicted values normalized for ethnicity, sex, age and height according to Global Lung Function Initiative algorithms will be determined.
Global health-related quality of life (HR-QL) score as assessed by Eastern Co-operative Oncology Group QLQ-C30 questionnaire
时间窗: One year postoperatively
"Global health" HR-QL scores at one year postoperatively among disease-free patients will be compared between neoadjuvant chemotherapy and chemoradiation cohorts
Change in DLCO following administration of neoadjuvant chemotherapy versus chemoradiation
时间窗: 4-6 weeks post completion of neoadjuvant therapy
Changes in DLCO (pulmonary diffusion capacity for carbon monoxide, mmol·min.-1.kPa. -1), both as a raw value, and as percentage of predicted values normalized for ethnicity, sex, age and height according to Global Lung Function Initiative algorithms will be determined.
Incidence of postoperative pulmonary morbidity as per Esophagectomy Complications Consensus Group (ECCG) definitions
时间窗: Up to 90 days postoperatively
Incidence of postoperative pulmonary morbidity, defined according to ECCG guidelines, will be compared after neoadjuvant chemotherapy versus chemoradiation.
Change in FVC following administration of neoadjuvant chemotherapy versus chemoradiation
时间窗: 4-6 weeks post completion of neoadjuvant therapy
Changes in FVC (forced vital capacity, litres), both as a raw value, and as percentage of predicted values normalized for ethnicity, sex, age and height according to Global Lung Function Initiative algorithms will be determined.
次要结局
- Disease-free survival(To date of study completion or date of disease recurrence, whichever occurs first, with a minimum of one year follow-up for all surviving patients)
- Overall survival(To date of study completion or date of death, whichever occurs first, with a minimum of one year follow-up for all surviving patients)
研究者
Dr Jessie A Elliott
Surgical Research Fellow
St. James's Hospital, Ireland