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NSCLCNCT02501707

Echocardiography for RILI Prediction

An observational study of NSCLC, run by Maastricht Radiation Oncology at 2 sites in Netherlands.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Severe radiation-induced lung injury (RILI) occurs in approximately 20% of the lung cancer patients, who are treated with curative chemoradiation. In this study the investigators want to evaluate the prognostic value of baseline cardiac function assessed with echocardiography for prediction of RILI. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
NSCLC
How many people
15 participants
Where
2 sitesNetherlands
Study dates
25 Apr 2017to 12 Sep 2019
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: All patients referred to MAASTRO Clinic with non-small cell lung cancer stage I-III disease can be included in this study (approximately 160 patients per year).

Who may be able to join

  • Clinical stage I-III non small cell lung cancer, excluding malignant pleural/pericardial effusion
  • Planned for curatively intended primary (chemo)radiotherapy, due to irresectable disease and/or medical inoperability
  • WHO performance status 0-2
  • No history of prior chest radiotherapy
  • No uncontrolled infectious disease
  • No other active malignancy
Show all 10Show fewer
  • No prior lung surgery (VATS, wedge resection, segment resection, lobectomy)
  • Willing and able to comply with the study prescriptions
  • 18 years or older
  • Ability to give and having given written informed consent before patient registration

Who cannot join

  • malignant pleural/pericardial effusion
  • history of prior chest radiotherapy
  • uncontrolled infectious disease
  • other active malignancy
  • prior lung surgery (VATS, wedge resection, segment resection, lobectomy)

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites

  • MAASTRO clinic

    Maastricht, Limburg, 6229 ET

  • Maastricht University Medical Center

    Maastricht, Limburg, 6229 HX

Other trials in Netherlands

About this study

Official title: The Value of Echocardiography for Prediction of Radiation-induced Lung Injury in Non-small Cell Lung Cancer Patients Treated With Chemoradiation: an Onco-cardiac Prospective Cohort Study.

Severe radiation-induced lung injury (RILI) occurs in approximately 20% of the lung cancer patients, who are treated with curative chemoradiation. In this study the investigators want to evaluate the prognostic value of baseline cardiac function assessed with echocardiography for prediction of RILI.

Read the detailed description

Severe radiation-induced lung injury (RILI) occurs in approximately 20% of the lung cancer patients, who are treated with curative chemoradiation (CRT).This side-effect can heavily impact quality of life and is a dose-limiting factor for the treatment. Identifying high risk patients before the start of the treatment would make it possible to adapt the treatment by choosing another radiation technique or proton therapy. However, despite the fact that many patient and treatment characteristics have been associated with RILI, it is not possible to accurately predict the risk of RILI for individual patients. Recently, it has been shown that the radiation dose to the heart is a risk factor for lung toxicity in both animal and clinical studies. Also, in a study, carried out jointly by CARIM and GROW, it was found that patients with a previous diagnosis of cardiac disease had a significantly higher risk to develop RILI after CRT (p-value <0.001), even with low or no radiation dose to the heart. It is unknown whether asymptomatic cardiac comorbidity is also related to development of RILI. Taking into account that approximately 30% of all lung cancer patients suffer from symptomatic cardiac comorbidity at the start of cancer treatment, there is an urgent need for research projects focusing on cardio-oncology. These projects will make it possible to unravel the complex relationship between heart, lungs, chemotherapy and radiation treatment. In the current project the investigators hypothesize that biomarkers based on echocardiography, which reflects cardiac function, are prognostic for development of radiation induced lung injury after chemoradiotherapy. In addition, the investigators will validate our previous finding that presence of cardiac comorbidity is associated with RILI.

Conditions
NSCLC
Keywords
echocardiography, radiation-induced lung injury, prognostic, chemo radiotherapy, non-small cell lung cancer, NSCLC
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dyspnea score at three months after (chemo)radiotherapy, assessed by the patient version of the CTCv4.0

    Measured: up to 3 months

Secondary outcomes (17)

  1. Dyspnea score at six months after (chemo)radiotherapy, assessed by the patient version of CTCv4.0

    Measured: up to 6 months

  2. Changes in dyspnea score after radiotherapy, compared to baseline

    Measured: up to 12 months

  3. Change in Left Ventricle Ejection Fraction (LVEF) (baseline versus 3-month after chemo radiation)

    Measured: up to 3 months

  4. Change in left atrial volume (2009 AHA/ESC guidelines)(baseline versus 3-month after chemo radiation)

    Measured: up to 3 months

  5. Radiation pneumonitis at 3-months after start of radio(chemo)therapy, assessed on a follow-up 3D CT scan image.

    Measured: up to 3 months

  6. Lung fibrosis score at 6-months after start of chemo radiation, assessed on a follow-up CT scan image

    Measured: up to 6 months

  7. Prevalence-based dyspnea measure, reflecting severity as well as duration of dyspnea

    Measured: up to 12 months

  8. Changes in physical activity levels and sedentary behavior, assessed by accelerometry

    Measured: up to 12 months

  9. Pulmonary function based on spirometry

    Measured: up to 3 months

  10. Change in left atrial ejection fraction (from pts in SR)(2009 AHA/ESC guidelines)(baseline versus 3-month after chemo radiation)

    Measured: up to 3 months

  11. Change in mitral inflow (2009 AHA/ESC guidelines)(baseline versus 3-month after chemo radiation)

    Measured: up to 3 months

  12. Change in pulmonary vein inflow patterns (2009 AHA/ESC guidelines)(baseline versus 3-month after chemo radiation)

    Measured: up to 3 months

  13. Change in tissue doppler patterns of the mitral annulus (2009 AHA/ESC guidelines)(baseline versus 3-month after chemo radiation)

    Measured: up to 3 months

  14. Cardiac blood biomarkers at baseline and during treatment, Brain natriuretic peptide(BNP), troponin I (TnI) and troponin T(TnT)

    Measured: up to 3 months

  15. Haemoglobin parameters in the blood at baseline and during treatment

    Measured: up to 3 months

  16. Inflammatory parameters (CRP, IL-6 and TNFa) in the blood at baseline and during treatment

    Measured: up to 3 months

  17. Time trends in physical activity and sedentary time from baseline till 12 months after radiotherapy, measured by accelerometers in four weekly periods

    Measured: up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2015 (estimated)
  2. Study start25 Apr 2017
  3. Primary completion12 Sep 2019
  4. Study completion12 Sep 2019

Why it stopped: The study is prematurely terminated due to bad inclusion and the fact that examinations are already being used in standard care.

Resources

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
Prospective
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02501707
Sponsor's protocol ID
echocardiographyRILI
Status last verified
Dec 2019
First submitted
13 Jul 2015
Last updated
4 Dec 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of NSCLC, run by Maastricht Radiation Oncology at 2 sites in Netherlands.

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 10 inclusion and 5 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: stopped early, as of the sponsor's last update on 4 Dec 2019. 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 Netherlands. 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 was stopped early (reason given: The study is prematurely terminated due to bad inclusion and the fact that examinations are already being used in standard care.). Results are not available in the source record.

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?

Dyspnea score at three months after (chemo)radiotherapy, assessed by the patient version of the CTCv4.0 (time frame: up to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02501707.

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 4 Dec 2019.

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