NCT05974475 MONDRIAN: Multi-omics Integrative Modelling for Stereotactic Body Radiotherapy in Early-stage Non-small Cell Lung Cancer
| NCT ID | NCT05974475 |
| Status | Recruiting |
| Phase | — |
| Sponsor | European Institute of Oncology |
| Condition | Lung Neoplasm Malignant |
| Study Type | OBSERVATIONAL |
| Enrollment | 270 participants |
| Start Date | 2023-09-11 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 270 participants in total. It began in 2023-09-11 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Stefania Volpe, MD
PRINCIPAL INVESTIGATOR
Istituto Europeo di Oncologia IRCCS
Frequently Asked Questions
Who can join the NCT05974475 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Neoplasm Malignant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05974475 currently recruiting?
Yes, NCT05974475 is actively recruiting participants. Contact the research team at stefania.volpe@ieo.it for enrollment information.
Where is the NCT05974475 trial being conducted?
This trial is being conducted at Milan, Italy, Milan, Italy.
Who is sponsoring the NCT05974475 clinical trial?
NCT05974475 is sponsored by European Institute of Oncology. The principal investigator is Stefania Volpe, MD at Istituto Europeo di Oncologia IRCCS. The trial plans to enroll 270 participants.