Clinical trial NCT03462524: Neoadjuvant Therapy for Esophageal Cancer and Cardiopulmonary Physiology
Official title: Neoadjuvant Therapy for Locally Advanced Esophageal Cancer: Impact on Cardiopulmonary Physiology, Short- and Long-term Morbidity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Cancer
Radiation Pneumonitis
Pulmonary Fibrosis
Respiratory Failure
Pneumonia
Surgery
Chemotherapy Effect
Radiation Fibrosis
Radiation Toxicity
Adenocarcinoma
Squamous Cell Carcinoma
Lead sponsor: St. James's Hospital, Ireland
Sponsor class: OTHER
First posted: 2018-03-12
Enrollment: 384
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Records for all patients with LAEC treated with multimodal therapy with curative intent between 2010 and 2016 will be assessed for inclusion. Patients undergoing emergent or palliative surgery, or salvage esophagectomy will be excluded. All eligible patients for whom pulmonary function testing was undertaken at our Centre at a minimum of one preoperative timepoint will be included for analysis of operative and/or oncologic outcome. Then, HR-QL among disease-free patients at least one year postoperatively will be assessed using validated questionnaires (EORTC QLQC30, OG25 and OES18).

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in FEV1 following administration of neoadjuvant chemotherapy versus chemoradiation
timeFrame: 4-6 weeks post completion of neoadjuvant therapy
measure: Change in FVC following administration of neoadjuvant chemotherapy versus chemoradiation
timeFrame: 4-6 weeks post completion of neoadjuvant therapy
measure: Change in DLCO following administration of neoadjuvant chemotherapy versus chemoradiation
timeFrame: 4-6 weeks post completion of neoadjuvant therapy
measure: Incidence of postoperative pulmonary morbidity as per Esophagectomy Complications Consensus Group (ECCG) definitions
timeFrame: Up to 90 days postoperatively
measure: Global health-related quality of life (HR-QL) score as assessed by Eastern Co-operative Oncology Group QLQ-C30 questionnaire
timeFrame: One year postoperatively
Secondary outcomes:
measure: Disease-free survival
timeFrame: 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
measure: Overall survival
timeFrame: To date of study completion or date of death, whichever occurs first, with a minimum of one year follow-up for all surviving patients
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Department of Surgery, St. James's Hospital
city: Dublin
country: Ireland
facility: Wellcome Trust-Health Research Board Clinical Research Facility, St. James's Hospital
Study officials:
References: