Cardiac ToxicityCOLANCT05258448
COr Loco-regional Advanced Lung Cancer Treated With Chemo-radiotherapy (COLA)
An observational study of Cardiac Toxicity and Lung Cancer Stage III, run by Odense University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Toxicity, Lung Cancer Stage III, Lung Cancer Stage II
- What is being tested?
- Chemoradiotherapy
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2015to Oct 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with locally advanced non-small-cell lung cancer will be included at the department of oncology at Odense University Hospital.
Who may be able to join
- 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.
Who cannot join
- Vulnerable patients.
- Patients with operable devices as pacemaker/ICD and cochlear implant or other conditions where MR scan is contraindicated.
- Claustrophobia.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Odense University Hospital
Odense C, 5000
Agon Olloni, MD, +4542206617, agon.olloni@rsyd.dk
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiac Toxicity, Lung Cancer Stage III, Lung Cancer Stage II, Radiation Toxicity, Cardiac Disease
- Being tested
- Chemoradiotherapy
- Medical subject headings
- Cardiotoxicity, Lung Neoplasms, Radiation Injuries, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemoradiotherapyOther
Cardiac Magnetic Resonance scan and ECG
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Chemoradiotherapy | |
| 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. Receives: Other: Chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
All cause mortality
Measured: 2 Years
Change in Left Ventricular Ejection Fraction
Change from baseline, evaluated by cardiac MR
Measured: 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.
Measured: 2 years.
Cardiovascular specific mortality
Assesed by patient interview and review of medical record
Measured: 2 years.
Secondary outcomes (4)
Late enhacment
Evaluated by cardiac MR.
Measured: At Baseline, 6, 12 and 24 months.
LVEDV changes
Left ventricular enddiastolic change in cMR
Measured: 2 years
LVESV changes
Left ventricular endsystolic change in cMR
Measured: 2 years
LV mass in gram
Left ventricular mass in gram.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study startAug 2015
- Primary completionAug 2024 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ToxicityStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agon Olloni, Odense University Hospital
- Investigators
- Tine Schytte, Professor, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05258448
- Sponsor's protocol ID
- S-20160086
- Acronym
- COLA
- Status last verified
- Dec 2023
- First submitted
- 3 Feb 2022
- Last updated
- 6 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Radiotherapy on the Heart in Loco-regional Advanced NSCLC Patients Treated With Definitive Radiotherapy Measured by Cardiac MR
- ClinicalTrials.gov ID
- NCT05258448
- Acronym / sponsor ID
- COLA / S-20160086
- Conditions
- Cardiac Toxicity, Lung Cancer Stage III, Lung Cancer Stage II, Radiation Toxicity, Cardiac Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 28 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COLA 1: Locally advanced non-small-cell lung cancer | – | Other: ChemoradiotherapyPatients 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 | – | Other: ChemoradiotherapyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with locally advanced non-small-cell lung cancer will be included at the department of oncology at Odense University Hospital.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Vulnerable patients.
- Patients with operable devices as pacemaker/ICD and cochlear implant or other conditions where MR scan is contraindicated.
- Claustrophobia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChemoradiotherapyCardiac Magnetic Resonance scan and ECG | Other | COLA 1: Locally advanced non-small-cell lung cancer, COLA 2 Locally advanced non-small-cell lung cancer |
Primary outcome
Overall survival
Time frame: 2 Years
All cause mortality
Change in Left Ventricular Ejection Fraction
Time frame: 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.
Time frame: 2 years.
Assesed by patient interview and review of medical record.
Cardiovascular specific mortality
Time frame: 2 years.
Assesed by patient interview and review of medical record
4 secondary outcomes
Late enhacment
Time frame: At Baseline, 6, 12 and 24 months.
LVEDV changes
Time frame: 2 years
LVESV changes
Time frame: 2 years
LV mass in gram
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tine Schytte, Professor principal investigator
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Toxicity and Lung Cancer Stage III, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Agon AO Olloni, MD (42206617, agon.olloni@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 2 Years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.