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

Odense University Hospital

Status: Enrolling

Conditions: Cardiac Toxicity; Radiation Toxicity; Cardiac Disease; Lung Cancer Stage II; Lung Cancer Stage III

Treatments: Other: Chemoradiotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT05258448

S-20160086

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

100 participants in 2 patient groups

COLA 1: Locally advanced non-small-cell lung cancer

Description:

Patients with locally advanced non-small-cell lung cancer treated with radiotherapy alone or in combination with chemotherapy with curative intent. Patients are included before initiation of the treatment. A Cardiac MR and ECG are performed at the beginning of the treatment, and at 6, 12, and 24 months after radiotherapy.

Treatment:

Other: Chemoradiotherapy

COLA 2 Locally advanced non-small-cell lung cancer

Description:

Patients with locally advanced non-small-cell lung cancer treated with radiotherapy alone or in combination with chemotherapy with curative intent. Patients not included in COLA 1 cohort are offered one cardiac MR and ECG between 12-24 months after radiotherapy treatment.

Treatment:

Other: Chemoradiotherapy