MONDRIAN: Multi-omics Integrative Modelling for Stereotactic Body Radiotherapy in Early-stage Non-small Cell Lung Cancer
Recruiting now
Conditions studied: Lung Neoplasm Malignant
In brief
Stereotactic Body Radiotherapy (SBRT) is a form of high-precision radiotherapy playing a major role in patients diagnosed with early-stage non-small cell lung cancer (NSLCL), especially when surgery cannot be performed. It is a non-invasive, well-tolerated treatment, with an excellent ability to control disease recurrence. However, in some patients, disease response is suboptimal: understanding why this happens may open doors to more aggressive approaches, such as the combination with systemic therapies. Hence, the goal of this observational trial is to understand which clinical, imaging, and biological factors are associated with response to SBRT through the development of complex models. In other words, the main question it aims to answer is: "Will this patient respond to radiation treatment based on the characteristics of their disease?". Participants will be treated according to the best clinical practice standards, in agreement with international, national, and internal guidelines. Researchers will compare data collected from patients treated with SBRT with those collected from a similar group of patients, who will be treated with surgery, to see which factors are actual predictors of response to SBRT, or rather are indicators of more or less aggressive disease behavior.
Key facts
- Study ID
- NCT05974475
- Run by
- European Institute of Oncology
- People needed
- 270
- Starts
- 2023-09-11
- Expected to finish
- 2028-09-01
- Last updated by the study team
- 2024-09-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically proven NSCLC; all histologies will be considered eligible (e.g. squamous, adenocarcinoma, large cell carcinoma);
- American Joint Committee on Cancer Tumor Node Metastasis (AJCC TNM) classification (8th Edition) clinical stage I-II;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- No absolute contraindications to either surgery (e.g. severe comorbidities) or SBRT (e.g. active connective diseases, severe pulmonary fibrosis);
- Ability and willingness to sign a written informed consent for treatment and study participation.
You may not qualify if…
- Prior diagnosis of invasive cancer (within 3 years before the diagnosis of ES-NSCLC);
- Mental diseases or psychiatric disorders preventing the acquisition of a valid informed consent.
Where it is running
- Istituto Europeo di Oncologia IRCCS — Milan, Italy, Italy (enrolling)
- Istituto Europeo di Oncologia (IEO) IRCCS — Milan, Lombardy, Italy (enrolling)
Full record on ClinicalTrials.gov
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