An observational study in Esophageal Cancer, Radiation Pneumonitis and Pulmonary Fibrosis, sponsored by St. James's Hospital, Ireland. Completed at 2 sites in Ireland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-12.
Sponsored by St. James's Hospital, Ireland · Observational
Among 10 studies in Esophageal Neoplasms by St. James's Hospital, Ireland — 1 open to participants now, 1 under way, none of them phase 3. Esophageal Neoplasms · St. James's Hospital, Ireland.
Among the 10 studies in Esophageal Neoplasms by St. James's Hospital, Ireland, this one is one of 2 that started in 2010, is one of 7 observational ones, and was the 6th registered.
1,873 studies on the registry are indexed under Esophageal Neoplasms; 501 are open to participants now.
Browse Esophageal Neoplasms studies →1 of the 10 studies in Esophageal Neoplasms by St. James's Hospital, Ireland is open now, in 1 country. Recruiting first, the newest first:
St. James's Hospital, Ireland · Sites in Ireland
By country, each count listing its studies:
Of the 387 Esophageal Neoplasms studies recruiting now, 245 (63%) set no upper age limit and 75 (19%) stop at 75 or younger; 19 take children under 18; 36 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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10 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 2 started in 2010.
This study's enrollment of 384 is above the median of 200 across 432 observational studies indexed under Esophageal Neoplasms.
Median enrollment 40 across the 3 interventional studies, 384 across the 7 observational. Of the 8 that completed or were terminated, 0 (0%) have results posted.
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St. James's Hospital, Ireland is the lead sponsor of 28 studies on the registry; 6 are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Esophageal Neoplasms by St. James's Hospital, Ireland, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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).
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Exclusion Criteria:
Procedure: Esophagectomy
Procedure: Esophagectomy
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.
Change in FEV1 following administration of neoadjuvant chemotherapy versus chemoradiation
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.
Time frame: 4-6 weeks post completion of neoadjuvant therapy
Change in FVC following administration of neoadjuvant chemotherapy versus chemoradiation
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.
Time frame: 4-6 weeks post completion of neoadjuvant therapy
Change in DLCO following administration of neoadjuvant chemotherapy versus chemoradiation
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.
Time frame: 4-6 weeks post completion of neoadjuvant therapy
Incidence of postoperative pulmonary morbidity as per Esophagectomy Complications Consensus Group (ECCG) definitions
Incidence of postoperative pulmonary morbidity, defined according to ECCG guidelines, will be compared after neoadjuvant chemotherapy versus chemoradiation.
Time frame: Up to 90 days postoperatively
Global health-related quality of life (HR-QL) score as assessed by Eastern Co-operative Oncology Group QLQ-C30 questionnaire
"Global health" HR-QL scores at one year postoperatively among disease-free patients will be compared between neoadjuvant chemotherapy and chemoradiation cohorts
Time frame: One year postoperatively
Disease-free survival
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.
Time frame: 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
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.
Time frame: To date of study completion or date of death, whichever occurs first, with a minimum of one year follow-up for all surviving patients
Plan to share: Undecided
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Ran from Jan 2010 to primary completion in Jan 2016, 72 months.
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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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St. James's Hospital, Ireland