Adenocarcinoma, Chemotherapy Effect, Esophageal Cancer, Pneumonia, Pulmonary Fibrosis, Radiation Fibrosis, Radiation Pneumonitis, Radiation Toxicity, Respiratory Failure, Squamous Cell Carcinoma, Surgery
Conditions
Brief summary
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.
Interventions
PROCEDUREEsophagectomy
FEV1, FVC and DLCO will be assessed at baseline and one month post induction therapy. Radiation induced lung injury (RILI EORTC grade≥2), CCI, Clavien-Dindo, and pulmonary complications will be monitored. Changes in pulmonary function will be compared with cardiorespiratory symptoms and HR-QL among disease-free survivors.
Sponsors
St. James's Hospital, Ireland
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Salvage, palliative or emergency surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in FVC following administration of neoadjuvant chemotherapy versus chemoradiation | 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. |
| Incidence of postoperative pulmonary morbidity as per Esophagectomy Complications Consensus Group (ECCG) definitions | Up to 90 days postoperatively | Incidence of postoperative pulmonary morbidity, defined according to ECCG guidelines, will be compared after neoadjuvant chemotherapy versus chemoradiation. |
| Global health-related quality of life (HR-QL) score as assessed by Eastern Co-operative Oncology Group QLQ-C30 questionnaire | 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 FEV1 following administration of neoadjuvant chemotherapy versus chemoradiation | 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. |
| Change in DLCO following administration of neoadjuvant chemotherapy versus chemoradiation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Disease-free survival will be compared between neoadjuvant chemotherapy and chemoradiation groups using Kaplan-Meier methods, as well as multivariable Cox proportional hazards regression models adjusting for known prognostic factors. |
| 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 | Disease-free survival will be compared between neoadjuvant chemotherapy and chemoradiation groups using Kaplan-Meier methods, as well as multivariable Cox proportional hazards regression models adjusting for known prognostic factors. |
Countries
Ireland
Outcome results
None listed