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

NCT05258448 | Recruiting

• 1 other identifier: S-20160086
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Late enhacment

  At Baseline, 6, 12 and 24 months.

• LVEDV changes

  2 years

• LVESV changes

  2 years

• LV mass in gram

  2 years

Study Arms (2)

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

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

Interventions

Chemoradiotherapy OTHER

Cardiac Magnetic Resonance scan and ECG

COLA 1: Locally advanced non-small-cell lung cancer; COLA 2 Locally advanced non-small-cell lung cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Odense University Hospital

Odense C, 5000, Denmark

RECRUITING

MeSH Terms

Conditions

Cardiotoxicity; Lung Neoplasms; Radiation Injuries; Heart Diseases

Interventions

Chemoradiotherapy

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Wounds and Injuries; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Officials

• Tine Schytte, Professor

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Agon AO Olloni, MD

CONTACT

42206617; agon.olloni@rsyd.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, Phd Student

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 28, 2022
• Study Start: August 1, 2015
• Primary Completion: August 1, 2024
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 6, 2023

Record last verified: 2023-12

Locations

DK (1)