Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cardiac Changes After Stereotactic Radiotherapy for Early Stage NSCLC Cancer (HALO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03984019
Recruitment Status : Not yet recruiting
First Posted : June 12, 2019
Last Update Posted : June 12, 2019
Sponsor:
Collaborator:
Dutch Cancer Society
Information provided by (Responsible Party):
The Netherlands Cancer Institute

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?

Condition or disease Intervention/treatment Phase
Lung Cancer Stage I Lung Cancer Stage II Diagnostic Test: Cardiac condition measurements Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Cardiac Changes After Stereotactic Radiotherapy for Early Stage NSCLC Cancer
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
A
Radiotherapy; SBRT Additional cardiac diagnostics
Diagnostic Test: Cardiac condition measurements
Cardiac MRI, ECG, echocardiography, cardiac blood markers




Primary Outcome Measures :
  1. Percentage of patients with a change in cardiac condition [ Time Frame: 1 year ]
    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)

  2. Percentage of change in cardiac arrhythmia [ Time Frame: 1 year ]
    Percentage of change in ECG-derived QRS duration (s) between Pre- and Post-treatment values

  3. Percentage of change in fibrosis [ Time Frame: 1 year ]
    Percentage of change in MRI-derived Extra Cellular Volume (cc) between Pre- and Post-treatment values

  4. Percentage of change in hemodynamic function [ Time Frame: 1 year ]
    Percentage of change in MRI- and echocardiography-derived ejection fraction (%) between Pre- and Post-treatment values

  5. Binary change in pericarditis status [ Time Frame: 1 year ]
    Presence of pericarditis signs on MRI post-treatment while absence of pericarditis signs pre-treatment: yes/no


Secondary Outcome Measures :
  1. Local fibrosis [ Time Frame: 1 year ]
    Is there a correlation between the presence of local fibrosis and dose to this region

  2. Morphology changes [ Time Frame: 1 year ]
    Are changes in morphology visible on the MRI scans made during treatment, compared to the pre treatment MRIs



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Receive SBRT treatment for stage 1A-2B NSCLC
  • Closest distance between edge of tumor and heart < 3 cm

Exclusion Criteria:

  • Pacemaker/ICD
  • Renal function below GFR <60 ml/min/1.7m2

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984019


Contacts
Layout table for location contacts
Contact: Jose Belderbos, MD, PhD +31 20 512 9111 j.belderbos@nki.nl
Contact: Barbara Stam, PhD +31 20 512 9111 b.stam@nki.nl

Locations
Layout table for location information
Netherlands
Netherlands Cancer Institute Not yet recruiting
Amsterdam, Netherlands, 1066CX
Contact: Jose Belderbos, MD, PhD    +31 20 512 9111    j.belderbos@nki.nl   
Contact: Barbara Stam, PhD    +31 20 512 9111    b.stam@nki.nl   
Principal Investigator: José Belderbos, MD, PhD         
Amsterdam UMC, location AMC Not yet recruiting
Amsterdam, Netherlands, 1105AZ
Contact: Edith Dieleman, MD    +31205669111    e.m.dieleman@amc.uva.nl   
Sponsors and Collaborators
The Netherlands Cancer Institute
Dutch Cancer Society
Investigators
Layout table for investigator information
Principal Investigator: Jose Belderbos, MD, PhD The Netherlands Cancer Institute

Layout table for additonal information
Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT03984019     History of Changes
Other Study ID Numbers: M19CCR
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No data will be shared

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases