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

Cardiac Disease Clinical Trial

— COLA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05258448
• Other study ID #: S-20160086
• Status: Recruiting
• Start date: August 2015
• Est. completion date: October 2026

Study information

• Verified date: December 2023
• Source: Odense University Hospital
• Contact: Agon AO Olloni, MD
• Phone: 42206617
• Email: agon.olloni[@]rsyd.dk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2026
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Disease
• Cardiac Toxicity
• Cardiotoxicity
• Heart Diseases
• Lung Cancer Stage II
• Lung Cancer Stage III
• Lung Neoplasms
• Radiation Toxicity

Intervention

Other:
• Chemoradiotherapy
Cardiac Magnetic Resonance scan and ECG

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense C

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	All cause mortality	2 Years
Primary	Change in Left Ventricular Ejection Fraction	Change from baseline, evaluated by cardiac MR	Baseline, at 6, 12 and 24 months.
Primary	Number of participants with treatment related adverse events and cardiac disease after radiotherapy as assesed by CTCAE v4.0.	Assesed by patient interview and review of medical record.	2 years.
Primary	Cardiovascular specific mortality	Assesed by patient interview and review of medical record	2 years.
Secondary	Late enhacment	Evaluated by cardiac MR.	At Baseline, 6, 12 and 24 months.
Secondary	LVEDV changes	Left ventricular enddiastolic change in cMR	2 years
Secondary	LVESV changes	Left ventricular endsystolic change in cMR	2 years
Secondary	LV mass in gram	Left ventricular mass in gram.	2 years