Esophageal CancerNCT03462524
Neoadjuvant Therapy for Esophageal Cancer and Cardiopulmonary Physiology
An observational study of Esophageal Cancer and Radiation Pneumonitis, run by St. James's Hospital, Ireland at 2 sites in Ireland.
Trial summary
Although recent global trends indicate reduced postoperative mortality after esophagectomy, major morbidity, in particular pulmonary, remains high, with considerable health and economic costs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Radiation Pneumonitis, Pulmonary Fibrosis
- What is being tested?
- Esophagectomy
- Type of treatment
- Surgery or procedure
- How many people
- 384 participants
- Where
- 2 sitesIreland
- Study dates
- 1 Jan 2010to 1 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- Salvage, palliative or emergency surgery
Trial locations and contacts
2 sites in 1 country.
Ireland2 sites
Department of Surgery, St. James's Hospital
Dublin, D4
Wellcome Trust-Health Research Board Clinical Research Facility, St. James's Hospital
Dublin, D8
About this study
Official title: Neoadjuvant Therapy for Locally Advanced Esophageal Cancer: Impact on Cardiopulmonary Physiology, Short- and Long-term Morbidity
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
- Esophageal Cancer, Radiation Pneumonitis, Pulmonary Fibrosis, Respiratory Failure, Pneumonia, Surgery
- Being tested
- Esophagectomy
- Medical subject headings
- Esophageal Neoplasms, Radiation Pneumonitis, Pulmonary Fibrosis, Respiratory Insufficiency, Pneumonia, Radiation Fibrosis Syndrome, Radiation Injuries, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsophagectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant chemotherapy | Not described Receives: Procedure: Esophagectomy | |
| Neoadjuvant chemoradiation | Not described Receives: Procedure: Esophagectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: One year postoperatively
Secondary outcomes (2)
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.
Measured: 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.
Measured: To date of study completion or date of death, whichever occurs first, with a minimum of one year follow-up for all surviving patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start1 Jan 2010
- Primary completion1 Jan 2016
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. James's Hospital, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Jessie A Elliott, St. James's Hospital, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03462524
- Sponsor's protocol ID
- SJHDOS201701
- Status last verified
- Mar 2018
- First submitted
- 28 Feb 2018
- Last updated
- 12 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Therapy for Locally Advanced Esophageal Cancer: Impact on Cardiopulmonary Physiology, Short- and Long-term Morbidity
- ClinicalTrials.gov ID
- NCT03462524
- Acronym / sponsor ID
- SJHDOS201701
- Conditions
- Esophageal Cancer, Radiation Pneumonitis, Pulmonary Fibrosis, Respiratory Failure, Pneumonia, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- St. James's Hospital, IrelandUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 1 Jan 2016 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 12 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant chemotherapy | – | Procedure: Esophagectomy |
| Neoadjuvant chemoradiation | – | Procedure: Esophagectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Salvage, palliative or emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EsophagectomyFEV1, 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. | Procedure or surgery | Neoadjuvant chemoradiation, Neoadjuvant chemotherapy |
Primary outcome
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.
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.
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.
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.
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer and Radiation Pneumonitis, run by St. James's Hospital, Ireland at 2 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in FEV1 following administration of neoadjuvant chemotherapy versus chemoradiation (time frame: 4-6 weeks post completion of neoadjuvant therapy). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2018.