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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05258448

Acronym

COLA

Enrollment

100

Registered

2022-02-28

Start date

2015-08-31

Completion date

2026-10-31

Last updated

2023-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Disease, Cardiac Toxicity, Lung Cancer Stage II, Lung Cancer Stage III, Radiation Toxicity

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.

Interventions

OTHERChemoradiotherapy

Cardiac Magnetic Resonance scan and ECG

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Cardiovascular specific mortality	2 years.	Assesed by patient interview and review of medical record
Overall survival	2 Years	All cause mortality
Change in Left Ventricular Ejection Fraction	Baseline, at 6, 12 and 24 months.	Change from baseline, evaluated by cardiac MR
Number of participants with treatment related adverse events and cardiac disease after radiotherapy as assesed by CTCAE v4.0.	2 years.	Assesed by patient interview and review of medical record.

Secondary

Measure	Time frame	Description
Late enhacment	At Baseline, 6, 12 and 24 months.	Evaluated by cardiac MR.
LVEDV changes	2 years	Left ventricular enddiastolic change in cMR
LVESV changes	2 years	Left ventricular endsystolic change in cMR
LV mass in gram	2 years	Left ventricular mass in gram.

Countries

Denmark

Contacts

Primary ContactAgon AO Olloni, MD

agon.olloni@rsyd.dk42206617

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026