Pneumonitis in Older Lung Cancer Patients After Radiotherapy

NCT06480734 | Active Not Recruiting

• 1 other identifier: POLCAR
• Study Type: interventional
• Target: 62
• Locations: 2 countries
• Sites: 5

Brief Summary

The main goal of this trial is to establish the performance characteristics and to develop a decision-algorithm of a new symptom-based scoring system with respect to the identification of elderly lung cancer patients developing pneumonitis after radiotherapy. To assess the performance characteristics of the symptom-based scoring system for detection of radiation pneumonitis the receiver operating characteristic (ROC) curve is used to show the connection between sensitivity and specificity for every possible cut-off for the symptom-based scoring system and to select the optimal scoring point for detection of radiation pneumonitis. The area under the ROC curve (AUC) is calculated to prove the diagnostic ability of the scoring system. Secondary aims include patient satisfaction with the symptom-based scoring system (symptom-questionnaire, paper version).

Conditions

Lung Cancer

Keywords

Lung cancer; Radiotherapy; Pneumonitis; Scoring system

Outcome Measures

Primary Outcomes (1)

• Number of participants with symptomatic radiation pneumonitis (grade ≥2)

  Radiation pneumonitis will be assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

  start of radiotherapy until 24 weeks following radiotherapy

Secondary Outcomes (1)

• Rate of patient satisfaction

  at the end of radiotherapy

Study Arms (1)

Elderly patients with lung cancer and risk of pneumonitis

EXPERIMENTAL

Elderly patients (65 years or older) irradiated for lung cancer who receive a mean radiation dose to the ipsilateral lung \>13 Gy and, therefore, have an increased risk of developing radiation pneumonitis.

Other: symptom-based scoring system (symptom-questionnaire, paper version)

Interventions

symptom-based scoring system (symptom-questionnaire, paper version) OTHER

The patients are asked to complete a paper-based questionnaire (symptom-based scoring system, paper version) once a week during and up to 24 weeks following radiotherapy. The patients state and score symptoms potentially associated with pneumonitis, namely cough, shortness of breath and fever. Scoring points are assigned to severity of the symptoms, and sum scores are used to identify pneumonitis. During the radiotherapy course, patients complete the questionnaire prior to regular appointments with a physician. Following radiotherapy, they are contacted by phone (to minimize the number of hospital visits) once a week for completion of the questionnaire. In case of an increase of the total score when compared to baseline, patients receive a follow-up phone call after 3 days, are asked to come to the hospital as outpatients or are admitted to hospital.

Elderly patients with lung cancer and risk of pneumonitis

Eligibility Criteria

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

You may qualify if:

• Histologically proven lung cancer
• Indication for radiotherapy or chemoradiation
• Mean radiation dose to ipsilateral lung \>13 Gy
• Age ≥65 years
• Written informed consent
• Capacity of the patient to contract

You may not qualify if:

• Expected Non-Compliance
• Baseline score of \>4 points

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead
• University of Southern Denmark: collaborator
• Medical School Hamburg: collaborator

Study Sites (5)

Vejle Hospital, University Hospital of Southern Denmark

Vejle, Southern Denmark, 7100, Denmark

Location

Medical Practice for Radiotherapy and Radiation Oncology

Hanover, Lower Saxony, 30161, Germany

Location

Medical School Hamburg, Schwerin Campus

Schwerin, Mecklenburg-Vorpommern, 19055, Germany

Location

Malteser Hospital St. Franziskus

Flensburg, Schleswig-Holstein, 24939, Germany

Location

Department of Radiation Oncology, University of Lübeck and University Medical Center Schleswig-Holstein

Lübeck, Schleswig-Holstein, 23562, Germany

Location

MeSH Terms

Conditions

Lung Neoplasms; Pneumonia

Condition Hierarchy (Ancestors)

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

Study Officials

• Dirk Rades, MD, FASTRO

  University of Lubeck

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: multi-center prospective study

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: June 28, 2024
• Study Start: November 6, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); DE (4)