Actively Recruiting

Age: 18Years +
All Genders
NCT05974475

MONDRIAN: Multi-omics Integrative Modelling for Stereotactic Body Radiotherapy in Early-stage Non-small Cell Lung Cancer

Led by European Institute of Oncology · Updated on 2024-09-23

270

Participants Needed

2

Research Sites

259 weeks

Total Duration

On this page

Sponsors

E

European Institute of Oncology

Lead Sponsor

A

Associazione Italiana per la Ricerca sul Cancro

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

MONDRIAN: Multi-omics Integrative Modelling for Stereotactic Body Radiotherapy in Early-stage Non-small Cell Lung Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed non-small cell lung cancer of any histology (e.g., squamous, adenocarcinoma, large cell carcinoma)
  • Clinical stage I or II NSCLC according to AJCC TNM 8th Edition
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • No absolute contraindications for surgery or SBRT (e.g. severe comorbidities, active connective diseases, severe pulmonary fibrosis)
  • Ability and willingness to sign written informed consent for treatment and study participation
Not Eligible

You will not qualify if you...

  • Prior invasive cancer diagnosis within the last 3 years before early-stage NSCLC diagnosis
  • Mental illness or psychiatric disorders that prevent valid informed consent

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Istituto Europeo di Oncologia IRCCS

Milan, Italy, Italy, 20141

Actively Recruiting

2

Istituto Europeo di Oncologia (IEO) IRCCS

Milan, Lombardy, Italy, 20141

Actively Recruiting

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Research Team

S

Stefania Volpe, MD, PhD

CONTACT

C

Cristiana Fodor, MSc

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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