NCT02501707

Brief Summary

Severe radiation-induced lung injury (RILI) occurs in approximately 20% of the lung cancer patients, who are treated with curative chemoradiation. In this study the investigators want to evaluate the prognostic value of baseline cardiac function assessed with echocardiography for prediction of RILI.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2017

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 17, 2015

Completed
1.8 years until next milestone

Study Start

First participant enrolled

April 25, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2019

Completed
Last Updated

December 4, 2019

Status Verified

December 1, 2019

Enrollment Period

2.4 years

First QC Date

July 13, 2015

Last Update Submit

December 2, 2019

Conditions

NSCLC

Keywords

echocardiographyradiation-induced lung injuryprognosticchemo radiotherapynon-small cell lung cancerNSCLC

Outcome Measures

Primary Outcomes (1)

  • Dyspnea score at three months after (chemo)radiotherapy, assessed by the patient version of the CTCv4.0

    up to 3 months

Secondary Outcomes (17)

  • Dyspnea score at six months after (chemo)radiotherapy, assessed by the patient version of CTCv4.0

    up to 6 months

  • Changes in dyspnea score after radiotherapy, compared to baseline

    up to 12 months

  • Change in Left Ventricle Ejection Fraction (LVEF) (baseline versus 3-month after chemo radiation)

    up to 3 months

  • Change in left atrial volume (2009 AHA/ESC guidelines)(baseline versus 3-month after chemo radiation)

    up to 3 months

  • Radiation pneumonitis at 3-months after start of radio(chemo)therapy, assessed on a follow-up 3D CT scan image.

    up to 3 months

  • +12 more secondary outcomes

Other Outcomes (7)

  • Cardiac Comorbidity according to ICD v10

    up to 12 months

  • Radiomics (the evolving field of texture analysis) of normal tissue(heart and lung)

    up to 3 months

  • Mitochondrial DNA (prognostic value of mtDNA for development of RILI)

    up to 12 months

  • +4 more other outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients referred to MAASTRO Clinic with non-small cell lung cancer stage I-III disease can be included in this study (approximately 160 patients per year).

You may qualify if:

  • Clinical stage I-III non small cell lung cancer, excluding malignant pleural/pericardial effusion
  • Planned for curatively intended primary (chemo)radiotherapy, due to irresectable disease and/or medical inoperability
  • WHO performance status 0-2
  • No history of prior chest radiotherapy
  • No uncontrolled infectious disease
  • No other active malignancy
  • No prior lung surgery (VATS, wedge resection, segment resection, lobectomy)
  • Willing and able to comply with the study prescriptions
  • years or older
  • Ability to give and having given written informed consent before patient registration

You may not qualify if:

  • malignant pleural/pericardial effusion
  • history of prior chest radiotherapy
  • uncontrolled infectious disease
  • other active malignancy
  • prior lung surgery (VATS, wedge resection, segment resection, lobectomy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

MAASTRO clinic

Maastricht, Limburg, 6229 ET, Netherlands

Location

Maastricht University Medical Center

Maastricht, Limburg, 6229 HX, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

Bloodsamples and saliva samples will be collected according to the biobank protocol at Maastro clinic to explore the prognostic value of mitochondrial DNA for development of radiation-induced lung injury. Cardiac bloodmarkers: B-type Natriuretic Peptide (BNP), cardiac Troponin I and T will be measured. Haemoglobin and inflammatory parameters (CRP, IL-6 and TNFa)

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Dirk De Ruysscher, PhD.

    MAASTRO-clinic (senior researcher)

    PRINCIPAL INVESTIGATOR

  • Bas Kietselaer, MD,Phd

    AzM/MUMC (cardiologist)

    PRINCIPAL INVESTIGATOR

  • Judith van Loon, MD,PhD

    MAASTRO-clinic (radiation oncologist)

    PRINCIPAL INVESTIGATOR

  • Philippe Lambin, Prof,MD,Phd

    MAASTRO-clinic (radiation oncologist)

    PRINCIPAL INVESTIGATOR

  • Anne-Marie Dingemans, MD, PhD

    MAASTRO-clinic (pulmonogist)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2015

First Posted

July 17, 2015

Study Start

April 25, 2017

Primary Completion

September 12, 2019

Study Completion

September 12, 2019

Last Updated

December 4, 2019

Record last verified: 2019-12

Locations

NL(2)