Clinical trial · Interventional
Pneumonitis After Radiotherapy for Lung Cancer
Pneumonitis After Radiotherapy for Lung Cancer: A Symptom-Based Scoring System to Identify Patients Developing Radiation Pneumonitis
- 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)
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.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mobile Application | Other | — | UNRESOLVED |
| Questionnaire | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Participants irradiated for lung cancer
- description
- 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.
- interventionNames
- Diagnostic Test: Questionnaire
- Other: Mobile Application
Primary outcomes (1)
- measure
- Number of Participants With Grade ≥2 Radiation Pneumonitis
- timeFrame
- 24 weeks following radiotherapy
- description
- Radiation pneumonitis will been assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDRades D, Werner EM, Glatzel E, Eggert MC, Olbrich D, Tvilsted S, Bohnet S. Pneumonitis after radiotherapy for lung cancer (PARALUC): an interventional study to create a symptom-based scoring system for identification of patients developing radiation pneumonitis. BMC Cancer. 2020 Aug 20;20(1):785. doi: 10.1186/s12885-020-07291-5. PMID 32819311