Status:
RECRUITING
MONDRIAN: Multi-omics Integrative Modelling for Stereotactic Body Radiotherapy in Early-stage Non-small Cell Lung Cancer
Lead Sponsor:
European Institute of Oncology
Collaborating Sponsors:
Associazione Italiana per la Ricerca sul Cancro
Conditions:
Lung Neoplasm Malignant
Eligibility:
All Genders
18+ years
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 c...
Detailed Description
The overall planned duration of the study is 60 months. The project is structured into five main tasks, as following: * Task 1\_Clinical study: Routine clinical data will be collected from eligible ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 11 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT05974475
Start Date
September 11 2023
End Date
September 1 2028
Last Update
September 23 2024
Active Locations (2)
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1
Istituto Europeo di Oncologia IRCCS
Milan, Italy, Italy, 20141
2
Istituto Europeo di Oncologia (IEO) IRCCS
Milan, Lombardy, Italy, 20141