MONDRIAN: Multi-omics Integrative Modelling for Stereotactic Body Radiotherapy in Early-stage Non-small Cell Lung Cancer
MONDRIAN
1 other identifier
observational
270
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2023
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2023
CompletedFirst Posted
Study publicly available on registry
August 3, 2023
CompletedStudy Start
First participant enrolled
September 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2028
September 23, 2024
September 1, 2024
3 years
July 26, 2023
September 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS)
The time between the beginning of SBRT or date of surgery, and any disease progression (local, regional, distant), death from any cause, or last follow-up, whichever comes first.
24 months
Study Arms (2)
SBRT Cohort
Radiation: Stereotactic Body Radiotherapy (SBRT)
Surgery Cohort
Procedure: Surgery
Interventions
State-of-art SBRT will be delivered in 3-5 fractions; prescription doses and fractionation schedules will be defined according to patient- and tumor-related characteristics (e.g. pulmonary comorbidities, tumor location: peripheral vs central vs ultra-central).
State-of-art surgery will be consist in pulmonary anatomical resection (i.e. segmentectomy or lobectomy) and systematic lymph node dissection.
Eligibility Criteria
Tertiary care cancer center, early-stage NSCLC.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Istituto Europeo di Oncologia IRCCS
Milan, Italy, 20141, Italy
Istituto Europeo di Oncologia (IEO) IRCCS
Milan, Lombardy, 20141, Italy
Related Publications (1)
Volpe S, Zaffaroni M, Piperno G, Vincini MG, Zerella MA, Mastroleo F, Cattani F, Fodor CI, Bellerba F, Bonaldi T, Bonizzi G, Ceci F, Cremonesi M, Fusco N, Gandini S, Garibaldi C, Torre D, Noberini R, Petralia G, Spaggiari L, Venetis K, Orecchia R, Casiraghi M, Jereczek-Fossa BA. Multi-omics integrative modelling for stereotactic body radiotherapy in early-stage non-small cell lung cancer: clinical trial protocol of the MONDRIAN study. BMC Cancer. 2023 Dec 15;23(1):1236. doi: 10.1186/s12885-023-11701-9.
PMID: 38102575DERIVED
Biospecimen
Formalin-fixed paraffin-embedded (FFPE) bioptic samples (SBRT cohort); formalin-fixed paraffin-embedded (FFPE) surgical specimens (surgical cohort)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stefania Volpe, MD
Istituto Europeo di Oncologia IRCCS
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 24 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2023
First Posted
August 3, 2023
Study Start
September 11, 2023
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2028
Last Updated
September 23, 2024
Record last verified: 2024-09