Clinical trial · Interventional
Pneumonitis in Older Lung Cancer Patients After Radiotherapy
Pneumonitis in Older Lung Cancer Patients After Radiotherapy: a Scoring System for Identification of Pneumonitis in Elderly Patients Irradiated for Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| symptom-based scoring system (symptom-questionnaire, paper version) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Elderly patients with lung cancer and risk of pneumonitis
- description
- 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.
- interventionNames
- Other: symptom-based scoring system (symptom-questionnaire, paper version)
Primary outcomes (1)
- measure
- Number of participants with symptomatic radiation pneumonitis (grade ≥2)
- timeFrame
- start of radiotherapy until 24 weeks following radiotherapy
- description
- Radiation pneumonitis will be assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically proven lung cancer 2. Indication for radiotherapy or chemoradiation 3. Mean radiation dose to ipsilateral lung \>13 Gy 4. Age ≥65 years 5. Written informed consent 6. Capacity of the patient to contract Exclusion Criteria: 1. Expected Non-Compliance 2. Baseline score of \>4 points
References
Publications (0)
Data not yet available