Clinical trial NCT05258448: COr Loco-regional Advanced Lung Cancer Treated With Chemo-radiotherapy (COLA)
Official title: The Effect of Radiotherapy on the Heart in Loco-regional Advanced NSCLC Patients Treated With Definitive Radiotherapy Measured by Cardiac MR
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Toxicity
Lung Cancer Stage III
Lung Cancer Stage II
Radiation Toxicity
Cardiac Disease
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2022-02-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with locally advanced non-small-cell lung cancer will be included at the department of oncology at Odense University Hospital.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival
timeFrame: 2 Years
measure: Change in Left Ventricular Ejection Fraction
timeFrame: Baseline, at 6, 12 and 24 months.
measure: Number of participants with treatment related adverse events and cardiac disease after radiotherapy as assesed by CTCAE v4.0.
timeFrame: 2 years.
measure: Cardiovascular specific mortality
timeFrame: 2 years.
Secondary outcomes:
measure: Late enhacment
timeFrame: At Baseline, 6, 12 and 24 months.
measure: LVEDV changes
timeFrame: 2 years
measure: LVESV changes
timeFrame: 2 years
measure: LV mass in gram
timeFrame: 2 years
Other outcomes:
Locations:
city: Odense C
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Tine Schytte, Professor
role: PRINCIPAL_INVESTIGATOR
References: