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

Recruiting

• Conditions: Cardiac Toxicity; Lung Cancer Stage III; Lung Cancer Stage II; Radiation Toxicity; Cardiac Disease
• Interventions: Other: Chemoradiotherapy

• Registration Number: NCT05258448
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2022-02-03
• Study First Submitted QC: 2022-02-16
• Study First Posted: 2022-02-28
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-05
• Last Update Posted: 2023-12-06
• Primary Completion: 2024-08
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COLA 1: Locally advanced non-small-cell lung cancer	Chemoradiotherapy	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.
COLA 2 Locally advanced non-small-cell lung cancer	Chemoradiotherapy	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.

Primary Outcome Measures

Name	Time	Method
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.
Cardiovascular specific mortality	2 years.	Assesed by patient interview and review of medical record

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense C, Denmark