Cardiac Changes After Stereotactic Radiotherapy for Early Stage NSCLC Cancer or Lung Metastasis

NCT03984019 | Terminated

• 1 other identifier: M19CCR
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

Brief Summary

The investigators aim to optimize the radiation treatment of early stage lung cancer patients. Therefore, detailed understanding is needed of the type of toxicity and the location of these toxicities for patients who receive high fraction doses. These have not been measured in these patients before, therefore our primary research question is: is it possible to measure changes in cardiac condition after radiotherapy, with respect to cardiac arrhythmias, fibrosis, hemodynamic function change and pericarditis?

Conditions

Lung Cancer Stage I; Lung Cancer Stage II; Lung Metastases

Outcome Measures

Primary Outcomes (5)

• Percentage of patients with a change in cardiac condition

  Percentage of patients with at least 5% change in cardiac arrhythmia (outcome 2) and/or at least 5% change in fibrosis (outcome 3) and/or at least 5% change in hemodynamic function (outcome 4) and/or development of pericarditis post-treatment (outcome 5)

  1 year

• Percentage of change in cardiac arrhythmia

  Percentage of change in ECG-derived QRS duration (s) between Pre- and Post-treatment values

  1 year

• Percentage of change in fibrosis

  Percentage of change in MRI-derived Extra Cellular Volume (cc) between Pre- and Post-treatment values

  1 year

• Percentage of change in hemodynamic function

  Percentage of change in MRI- and echocardiography-derived ejection fraction (%) between Pre- and Post-treatment values

  1 year

• Binary change in pericarditis status

  Presence of pericarditis signs on MRI post-treatment while absence of pericarditis signs pre-treatment: yes/no

  1 year

Secondary Outcomes (2)

• Local fibrosis

  1 year

• Morphology changes

  1 year

Study Arms (1)

A

OTHER

Radiotherapy; SBRT Additional cardiac diagnostics

Diagnostic Test: Cardiac condition measurements

Interventions

Cardiac condition measurements DIAGNOSTIC_TEST

Cardiac MRI, ECG, echocardiography, cardiac blood markers

A

Eligibility Criteria

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

You may qualify if:

• Receive SBRT treatment for stage 1A-2B NSCLC or for a solitary lung metastasis of a solid tumour
• Closest distance between edge of tumor and heart \< 3 cm

You may not qualify if:

• Pacemaker/ICD
• Renal function below GFR \<30 ml/min/1.7m2

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead
• Dutch Cancer Society: collaborator

Study Sites (3)

Netherlands Cancer Institute

Amsterdam, 1066CX, Netherlands

Location

Amsterdam UMC, location AMC

Amsterdam, 1105AZ, Netherlands

Location

Leids Universitair Medisch Centrum (LUMC)

Leiden, 2333ZA, Netherlands

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jose Belderbos, MD, PhD

  The Netherlands Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an exploratory study to determine whether cardiac changes occur after radiation treatment. Patients are treated following standard clinical practice, with additional diagnostic investigations. The study design is therefore a cohort study.

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: June 12, 2019
• Study Start: January 13, 2021
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: May 24, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3)