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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Radiation Toxicity; Cardiac Disease; Cardiac Toxicity; Lung Cancer Stage III; Lung Cancer Stage II
• Intervention / Treatment: Other: Chemoradiotherapy

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Agon AO Olloni, MD; Phone Number: 42206617; Email: agon.olloni@rsyd.dk

Study Locations

• Denmark
  • Odense C, Denmark, 5000
    • Recruiting
    • Odense University Hospital
    • Contact: Agon Olloni, MD; Phone Number: +4542206617; Email: agon.olloni@rsyd.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COLA 1: Locally advanced non-small-cell lung cancer; 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.	Other: Chemoradiotherapy; Cardiac Magnetic Resonance scan and ECG
COLA 2 Locally advanced non-small-cell lung cancer; 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.	Other: Chemoradiotherapy; Cardiac Magnetic Resonance scan and ECG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	All cause mortality	2 Years
Change in Left Ventricular Ejection Fraction	Change from baseline, evaluated by cardiac MR	Baseline, at 6, 12 and 24 months.
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.
Cardiovascular specific mortality	Assesed by patient interview and review of medical record	2 years.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Investigators: Principal Investigator: Tine Schytte, Professor, Odense University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: February 3, 2022
• First Submitted That Met QC Criteria: February 16, 2022
• First Posted (Actual): February 28, 2022

Study Record Updates

• Last Update Posted (Estimated): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Cardiovascular Diseases; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Wounds and Injuries; Respiratory Tract Neoplasms; Thoracic Neoplasms; Drug-Related Side Effects and Adverse Reactions; Radiation Injuries; Heart Diseases; Lung Neoplasms; Cardiotoxicity
• Other Study ID Numbers: S-20160086

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No