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Pneumonitis After Radiotherapy for Lung Cancer (PARALUC)

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: NCT04335409
Recruitment Status : Recruiting
First Posted : April 6, 2020
Last Update Posted : April 29, 2021
Sponsor:
Collaborator:
Zealand University Hospital
Information provided by (Responsible Party):
Prof. Dirk Rades, MD, University Hospital Schleswig-Holstein

Brief Summary:

Major goals of radiotherapy include local disease control and improvement of the patients' prognoses. One possible side effect of radiotherapy for lung cancer is radiation pneumonitis. Severe (grade ≥3) radiation pneumonitis can even be fatal in approximately 2% of the patients. It would be important to identify patients developing radiation pneumonitis and requiring medical treatment early.

In the present study, the patients are asked to complete a questionnaire (paper version) once a week during the period of radiotherapy and up to 24 weeks following radiotherapy. In this questionnaire, the patients are asked to state and rate their symptoms potentially associated with pneumonitis. Scoring points are assigned to the severity of the symptoms (symptom scores), and the resulting sum score (patient score) will be used for identification of radiation pneumonitis.

The main goal of this trial is to evaluate the usefulness of a new symptom-based scoring system with respect to the identification of patients developing pneumonitis after radiotherapy of breast or lung cancer. The discriminative power of the symptom-based scoring system will be assessed by calculating the area under the ROC curve (AUC). Taking into account that 5% of patients will not qualify for Full Analysis Set, a total of 78 patients should be recruited.

If statistical significance of the AUC is reached, the most-informative (optimal) scoring point to identify radiation pneumonitis will be derived. Sensitivity analyses will be conducted to further investigate the performance of the symptom-based scoring system.

In 10 patients, the paper version of the symptom-based scoring system (questionnaire) will be supplemented by a mobile application (app) asking the same questions regarding symptoms potentially associated with radiation pneumonitis.


Condition or disease Intervention/treatment Phase
Lung Cancer Diagnostic Test: Questionnaire Other: Mobile Application Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pneumonitis After Radiotherapy for Lung Cancer: A Symptom-Based Scoring System to Identify Patients Developing Radiation Pneumonitis
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: Participants irradiated for lung cancer
Participants who receive radiotherapy for lung cancer and have risk factors for developing radiation pneumonitis. Risk factors include mean dose to the ipsilateral lung >13 Gy plus at least one other factor (significant cardiovascular disease, history of heavy smoking (≥40 pack years), previous/concurrent chemotherapy or previous/adjuvant immunotherapy) or mean dose to the ipsilateral lung >20 Gy without other factors.
Diagnostic Test: Questionnaire
The patients are asked to complete a questionnaire (paper version) once a week during the period of radiotherapy and up to 24 weeks following radiotherapy. In this questionnaire, the patients are asked to state and rate their symptoms potentially associated with pneumonitis. Scoring points are assigned to the severity of the symptoms (symptom scores), and the resulting sum score (patient score) will be used for identification of radiation pneumonitis.

Other: Mobile Application
In 10 patients, the paper version of the symptom-based scoring system (questionnaire) will be supplemented by a mobile application (app) asking the same questions regarding symptoms potentially associated with pneumonitis.




Primary Outcome Measures :
  1. Number of Participants With Grade ≥2 Radiation Pneumonitis [ Time Frame: 24 weeks following radiotherapy ]
    Radiation pneumonitis will been assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically proven lung cancer
  2. Indication for radiotherapy
  3. Risk factors for developing radiation pneumonitis
  4. Age ≥18 years
  5. Written informed consent
  6. Capacity of the patient to contract

Exclusion Criteria:

  1. Pregnancy, Lactation
  2. Expected non-compliance

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): NCT04335409


Contacts
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Contact: Dirk Rades, MD 0049 451 500 ext 45401 dirk.rades@uksh.de
Contact: Elisa M Werner 0049 451 500 ext 45401 ElisaMarie.Werner@uksh.de

Locations
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Germany
Department of Radiation Oncology, University of Lübeck and University Medical Center Schleswig-Holstein, Ratzeburger Allee 160, 23562 Lübeck, Germany Recruiting
Lubeck Hansestadt, Germany, 23562
Contact: Dirk Rades, Professor    +49-451-500-45400    dirk.rades@uksh.de   
Contact: Kirsten Hakelberg, Dr. med.    +49-451-500-45410    kirsten.hakelberg@uksh.de   
Sponsors and Collaborators
University Hospital Schleswig-Holstein
Zealand University Hospital
Investigators
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Principal Investigator: Dirk Rades, MD Department of Radiation Oncology, University of Lübeck, Germany
  Study Documents (Full-Text)

Documents provided by Prof. Dirk Rades, MD, University Hospital Schleswig-Holstein:
Informed Consent Form  [PDF] July 2, 2020

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Dirk Rades, MD, Professor and Chair, University Hospital Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT04335409    
Other Study ID Numbers: PARALUC
First Posted: April 6, 2020    Key Record Dates
Last Update Posted: April 29, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Infections