MedTrace Logo

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

NCT05974475 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 270

Last updated 2024-09-23

No results posted yet for this study

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.

Conditions

  • Lung Neoplasm Malignant

Interventions

RADIATION

SBRT

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).

PROCEDURE

Surgery

State-of-art surgery will be consist in pulmonary anatomical resection (i.e. segmentectomy or lobectomy) and systematic lymph node dissection.

Sponsors & Collaborators

  • Associazione Italiana per la Ricerca sul Cancro

    collaborator OTHER

  • European Institute of Oncology

    lead OTHER

Principal Investigators

  • Stefania Volpe, MD · Istituto Europeo di Oncologia IRCCS

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-11
Primary Completion
2026-09-30
Completion
2028-09-30

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05974475 on ClinicalTrials.gov