Neoadjuvant Therapy for Esophageal Cancer and Cardiopulmonary Physiology

St. James's Hospital, Ireland

Status: Completed

Conditions: Pulmonary Fibrosis; Chemotherapy Effect; Squamous Cell Carcinoma; Radiation Fibrosis; Respiratory Failure; Radiation Toxicity; Esophageal Cancer; Surgery; Radiation Pneumonitis; Pneumonia; Adenocarcinoma

Treatments: Procedure: Esophagectomy

Study type: Observational

Funder types: Other

Identifiers

NCT03462524

SJHDOS201701

Details and patient eligibility

About

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.

Enrollment: 384 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

384 participants in 2 patient groups

Neoadjuvant chemotherapy

Treatment:

Procedure: Esophagectomy

Neoadjuvant chemoradiation

Treatment:

Procedure: Esophagectomy