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Neoadjuvant Therapy for Esophageal Cancer and Cardiopulmonary Physiology

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ClinicalTrials.gov Identifier: NCT03462524
Recruitment Status : Completed
First Posted : March 12, 2018
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
Dr Jessie A Elliott, St. James's Hospital, Ireland

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.


Condition or disease Intervention/treatment
Esophageal Cancer Radiation Pneumonitis Pulmonary Fibrosis Respiratory Failure Pneumonia Surgery Chemotherapy Effect Radiation Fibrosis Radiation Toxicity Adenocarcinoma Squamous Cell Carcinoma Procedure: Esophagectomy

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Study Type : Observational
Actual Enrollment : 384 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Neoadjuvant Therapy for Locally Advanced Esophageal Cancer: Impact on Cardiopulmonary Physiology, Short- and Long-term Morbidity
Actual Study Start Date : January 1, 2010
Actual Primary Completion Date : January 1, 2016
Actual Study Completion Date : January 1, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Neoadjuvant chemotherapy 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.

Neoadjuvant chemoradiation 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.




Primary Outcome Measures :
  1. Change in FEV1 following administration of neoadjuvant chemotherapy versus chemoradiation [ Time Frame: 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.

  2. Change in FVC following administration of neoadjuvant chemotherapy versus chemoradiation [ Time Frame: 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.

  3. Change in DLCO following administration of neoadjuvant chemotherapy versus chemoradiation [ Time Frame: 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.

  4. Incidence of postoperative pulmonary morbidity as per Esophagectomy Complications Consensus Group (ECCG) definitions [ Time Frame: Up to 90 days postoperatively ]
    Incidence of postoperative pulmonary morbidity, defined according to ECCG guidelines, will be compared after neoadjuvant chemotherapy versus chemoradiation.

  5. Global health-related quality of life (HR-QL) score as assessed by Eastern Co-operative Oncology Group QLQ-C30 questionnaire [ Time Frame: 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


Secondary Outcome Measures :
  1. Disease-free survival [ 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 ]
    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.

  2. Overall survival [ 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 ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03462524


Locations
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Ireland
Department of Surgery, St. James's Hospital
Dublin, Ireland, D4
Wellcome Trust-Health Research Board Clinical Research Facility, St. James's Hospital
Dublin, Ireland, D8
Sponsors and Collaborators
St. James's Hospital, Ireland
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Responsible Party: Dr Jessie A Elliott, Surgical Research Fellow, St. James's Hospital, Ireland
ClinicalTrials.gov Identifier: NCT03462524    
Other Study ID Numbers: SJHDOS201701
First Posted: March 12, 2018    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Esophageal Neoplasms
Pneumonia
Respiratory Insufficiency
Pulmonary Fibrosis
Radiation Pneumonitis
Fibrosis
Neoplasms
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Respiration Disorders
Lung Diseases, Interstitial
Lung Injury
Radiation Injuries
Wounds and Injuries