Stereotactic Ablative Radiotherapy for Oligo-Metastatic Non-Small Cell Lung Cancer

STereotactic Ablative RadioTherapy in NEWly Synchronous and mEtachRonous (Oligo-persistence, Oligo-induced, Oligo-progression) Oncogene and Non Oncogene Addicted OLIGO-metastatic Non-small Cell Lung Cancer Patients

This study is testing if a special type of radiation therapy can help people with non-small cell lung cancer that has spread to a few other places in the body live longer and feel better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Radiotherapy Oncology Centre "Santa Maria" Hospital (other)
• Drugs / interventions: radiation, chemotherapy, Immunotherapy
• Locations: 1 site (Terni, TR)
• Trial ID: NCT06207292 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of stereotactic ablative radiotherapy (SABR) in patients with synchronous and metachronous oligo-metastatic non-small cell lung cancer (NSCLC). It focuses on patients with 1-5 metastatic lesions, aiming to improve overall survival by treating both the primary tumor and metastatic sites. The study is non-randomized and conducted at a single institution, utilizing advanced imaging techniques to confirm eligibility and treatment targets. The integration of SABR with targeted therapies and immunotherapy is also being explored, as previous trials have shown promising results in similar patient populations.

Who should consider this trial

Good fit: Ideal candidates include patients with histologically confirmed NSCLC and 1-5 metastatic lesions, either synchronous or metachronous.

Not a fit: Patients with extensive metastatic disease beyond 5 lesions or those with uncontrolled brain metastases may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve survival rates for patients with oligo-metastatic NSCLC.

How similar studies have performed: Previous clinical trials have demonstrated prolonged survival in oligo-metastatic NSCLC patients treated with SABR, indicating a promising approach.

Eligibility criteria

Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
* histologically confirmed NSCLC
* synchronous oligo-M NSCLC as determined by Positron emission tomography- computed tomography (PET/CT) and brain MRI (AJCC 8th edition)
* metachronous oligo-M NSCLC (oligo-persistence, oligo-progressive, oligo-induced) as determined by PET/CT and brain magnetic resonance imaging (MRI) (AJCC 8th edition)
* patients with at least one target to be treated by SABR at the body
* patients with brain metastases synchronous to the body will be enrolled only if amenable to radiosurgery (the number of brain metastases does not enter into the count of the number of oligo-M)
* patients with a previous history of brain metastases will be enrolled only if the previously treated brain metastases are in control

Exclusion Criteria:

* Ability to understand and the willingness to sign an institutional review board (IRB)- approved informed consent document (either directly or via a legally authorized representative)
* Inability to safely treat target lesions
* Pregnant women are excluded from this study because radiation therapy has known potential for teratogenic or abortifacient effects.

Where this trial is running

Terni, TR

• Radiotherapy Oncology Centre "S.Maria" Hospital — Terni, TR, Italy (RECRUITING)

Study contacts

• Principal investigator: Fabio Arcidiacono, MD — Radiotherapy Oncology Centre "S.Maria" Hospital, Terni
• Study coordinator: Fabio Arcidiacono, MD

Conditions: NSCLC, NSCLC Stage IV, Oligometastatic Disease, Non Small Cell Lung Cancer, Non Small Cell Lung Cancer Metastatic, EGF-R Positive Non-Small Cell Lung Cancer, NSCLC Stage IV Without EGFR/ALK Mutation, Non-Small Cell Adenocarcinoma