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

NCT ID: NCT05258448

Last Updated: 2023-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-31

Study Completion Date

2026-10-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Chemoradiotherapy

Intervention Type OTHER

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.

Chemoradiotherapy

Intervention Type OTHER

Cardiac Magnetic Resonance scan and ECG

Interventions

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Chemoradiotherapy

Cardiac Magnetic Resonance scan and ECG

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Agon Olloni

Principal Investigator, MD, Phd Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tine Schytte, Professor

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Locations

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Odense University Hospital

Odense C, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Agon AO Olloni, MD

Role: CONTACT

Phone: 42206617

Email: [email protected]

Facility Contacts

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Agon Olloni, MD

Role: primary

Other Identifiers

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S-20160086

Identifier Type: -

Identifier Source: org_study_id