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NCT Number: NCT05258448

COr Loco-regional Advanced Lung Cancer Treated With Chemo-radiotherapy (COLA)

Patients with loco-regional NSCLC planned for curative treatment with chemoradiotherapy will be invited to participate in a prospective study; besides routine treatment, the patients will be followed with an ECG and cardiac MR for at least two years after radiotherapy treatment.

Recruiting

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Key information

About this study

Definitive chemo-radiotherapy is the treatment of choice for loco-regional advanced non-small cell lung cancer (LA-NSCLC). However, the treatment is associated with a range of side effects with radiation pneumonitis and esophagitis. In addition, the toxicity of the heart in lung cancer patients treated with radiotherapy has been offered less consideration. Therefore, it is essential to investigate the possible early and late toxicity to the heart and the baseline cardiac status of these patients. This study will describe cardiac comorbidity before radiotherapy treatment by a thorough history. Furthermore, we will evaluate heart function and evaluate possible heart disease by an ECG and cardiac MR. Patients will be followed with ECG and cardiac MR for two years after radiotherapy, detecting structural changes caused by radiotherapy and subclinical disease after radiotherapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 Years
  • Inoperable and histologically/cytologically verified NSCLC.
  • Planned treatment with curative intent.
  • Capable of completing study procedures ECG and Cardiac MR.
  • Able of giving written and informed consent before study procedures are initiated.

Exclusion criteria

  • Vulnerable patients.
  • Patients with operable devices as pacemaker/ICD and cochlear implant or other conditions where MR scan is contraindicated.
  • Claustrophobia.

Treatment and study plan

Chemoradiotherapy

Other

Cardiac Magnetic Resonance scan and ECG

Primary outcomes

  1. Overall survival

    Time frame: 2 Years

    All cause mortality

  2. Change in Left Ventricular Ejection Fraction

    Time frame: Baseline, at 6, 12 and 24 months.

    Change from baseline, evaluated by cardiac MR

  3. Number of participants with treatment related adverse events and cardiac disease after radiotherapy as assesed by CTCAE v4.0.

    Time frame: 2 years.

    Assesed by patient interview and review of medical record.

  4. Cardiovascular specific mortality

    Time frame: 2 years.

    Assesed by patient interview and review of medical record

Secondary outcomes

  1. Late enhacment

    Time frame: At Baseline, 6, 12 and 24 months.

    Evaluated by cardiac MR.

  2. LVEDV changes

    Time frame: 2 years

    Left ventricular enddiastolic change in cMR

  3. LVESV changes

    Time frame: 2 years

    Left ventricular endsystolic change in cMR

  4. LV mass in gram

    Time frame: 2 years

    Left ventricular mass in gram.

Study contacts

Contact information is provided by the study sponsor or research team.

Agon AO Olloni, MD

CONTACT

[email protected]

42206617

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study title

The Effect of Radiotherapy on the Heart in Loco-regional Advanced NSCLC Patients Treated With Definitive Radiotherapy Measured by Cardiac MR

Acronym: COLA

Important dates

Study start
2015
Primary completion
2024
Study completion
2026
First posted
Feb 28, 2022
Registry last updated
Dec 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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