Understanding response to stereotactic body radiotherapy in early-stage lung cancer
MONDRIAN: Multi-omics Integrative Modelling for Stereotactic Body Radiotherapy in Early-stage Non-small Cell Lung Cancer
This study is trying to understand why some people with early-stage lung cancer respond better to a specific type of radiation treatment than others, to help improve future treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 270 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | European Institute of Oncology Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Milan, Italy and 1 other locations) |
| Trial ID | NCT05974475 on ClinicalTrials.gov |
What this trial studies
This observational trial aims to investigate the factors influencing the response of early-stage non-small cell lung cancer (NSCLC) patients to stereotactic body radiotherapy (SBRT). It will collect clinical, imaging, and biological data to develop models that predict treatment outcomes. The study includes tasks such as analyzing routine clinical data, performing quantitative imaging analysis, and conducting gene expression and proteomics studies. The goal is to identify why some patients respond well to SBRT while others do not, potentially leading to improved treatment strategies.
Who should consider this trial
Good fit: Ideal candidates are patients with histologically proven early-stage non-small cell lung cancer who are eligible for SBRT and have an ECOG performance status of 0-1.
Not a fit: Patients with prior invasive cancer diagnoses within the last three years or those with severe comorbidities that contraindicate SBRT may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the ability to predict which patients will benefit from SBRT, leading to more personalized treatment approaches.
How similar studies have performed: Other studies have shown promise in using multi-omics approaches to understand cancer treatment responses, suggesting this methodology could be beneficial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Milan, Italy and 1 other locations
- Istituto Europeo di Oncologia IRCCS — Milan, Italy, Italy (Recruiting)
- Istituto Europeo di Oncologia (IEO) IRCCS — Milan, Lombardy, Italy (Recruiting)
Study contacts
- Principal investigator: Stefania Volpe, MD — Istituto Europeo di Oncologia IRCCS
- Study coordinator: Stefania Volpe, MD, PhD
- Email: stefania.volpe@ieo.it
- Phone: 0039 02 57489037
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.