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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOdense University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 Years

Inoperable and histologically/cytologically verified NSCLC.

Planned treatment with curative intent.

Capable of completing study procedures ECG and Cardiac MR.

Disqualifiers

Vulnerable patients.

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

Claustrophobia.

Trial population

Patients with locally advanced non-small-cell lung cancer will be included at the department of oncology at Odense University Hospital.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Chemoradiotherapy

    Other intervention

    Cardiac Magnetic Resonance scan and ECG

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: COLA 1: Locally advanced non-small-cell lung cancer1 intervention
Group B: COLA 2 Locally advanced non-small-cell lung cancer1 intervention

Trial outcomes

Primary outcomes

1

Overall survival

All cause mortality

Time frame
2 Years
2

Change in Left Ventricular Ejection Fraction

Change from baseline, evaluated by cardiac MR

Time frame
Baseline, at 6, 12 and 24 months.
3

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.

Time frame
2 years.
4

Cardiovascular specific mortality

Assesed by patient interview and review of medical record

Time frame
2 years.

Secondary outcomes

1

Late enhacment

Evaluated by cardiac MR.

Time frame
At Baseline, 6, 12 and 24 months.
2

LVEDV changes

Left ventricular enddiastolic change in cMR

Time frame
2 years
3

LVESV changes

Left ventricular endsystolic change in cMR

Time frame
2 years
4

LV mass in gram

Left ventricular mass in gram.

Time frame
2 years

Other outcomes

Sponsors and contacts

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