Clinical trial · Observational
Neoadjuvant Therapy for Esophageal Cancer and Cardiopulmonary Physiology
Neoadjuvant Therapy for Locally Advanced Esophageal Cancer: Impact on Cardiopulmonary Physiology, Short- and Long-term Morbidity
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma | Adenocarcinoma | ONTOLOGY_EXACT | 0.90 |
| Chemotherapy Effect | — | UNRESOLVED | — |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Pneumonia | — | UNRESOLVED | — |
| Pulmonary Fibrosis | — | UNRESOLVED | — |
| Radiation Fibrosis | — | UNRESOLVED | — |
| Radiation Pneumonitis | — | UNRESOLVED | — |
| Radiation Toxicity | — | UNRESOLVED | — |
| Respiratory Failure | — | UNRESOLVED |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Esophagectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Neoadjuvant chemotherapy
- interventionNames
- Procedure: Esophagectomy
- label
- Neoadjuvant chemoradiation
- interventionNames
- Procedure: Esophagectomy
Primary outcomes (5)
- measure
- Change in FEV1 following administration of neoadjuvant chemotherapy versus chemoradiation
- timeFrame
- 4-6 weeks post completion of neoadjuvant therapy
- description
- 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.
- measure
- Change in FVC following administration of neoadjuvant chemotherapy versus chemoradiation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available