Stereotactic Ablative Radiotherapy in Synchronous and Metachronous Oligo-Metastatic Non Small Cell Lung Cancer
Launched by RADIOTHERAPY ONCOLOGY CENTRE "SANTA MARIA" HOSPITAL · Jan 12, 2024
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a treatment called stereotactic ablative radiotherapy (SABR) for patients with a specific type of lung cancer known as non-small cell lung cancer (NSCLC) that has spread to a limited number of other places in the body, a condition called oligo-metastatic disease. The goal is to determine how safe and effective this treatment is for patients who have either recently developed new tumors or have had them in the past. Researchers want to see if SABR can help control the cancer in these patients.
To participate in this trial, patients need to be between the ages of 65 and 74 and must have a confirmed diagnosis of NSCLC. They should have a good performance status, which means they can carry out daily activities with minimal issues. Candidates must have a limited number of tumors that can be treated with SABR, and if they have brain metastases (cancer that has spread to the brain), those must be manageable. Participants can expect to receive focused radiation therapy aimed at their tumors, and the trial is currently recruiting patients who meet these criteria. It's important to note that pregnant women cannot participate in this study due to the potential risks associated with radiation.
Gender
ALL
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.
About Radiotherapy Oncology Centre "Santa Maria" Hospital
The Radiotherapy Oncology Centre at Santa Maria Hospital is a leading clinical trial sponsor dedicated to advancing cancer treatment through innovative research and cutting-edge radiotherapy techniques. With a commitment to improving patient outcomes and quality of life, the center collaborates with multidisciplinary teams of oncologists, researchers, and healthcare professionals to conduct rigorous clinical trials. By integrating state-of-the-art technology and evidence-based practices, the Santa Maria Hospital Radiotherapy Oncology Centre aims to enhance therapeutic strategies and contribute to the global fight against cancer.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Terni, Tr, Italy
Patients applied
Trial Officials
Fabio Arcidiacono, MD
Principal Investigator
Radiotherapy Oncology Centre "S.Maria" Hospital, Terni
Paola Anselmo, MD
Principal Investigator
Radiotherapy Oncology Centre "S.Maria" Hospital, Terni
Michelina Casale, PhD
Principal Investigator
Radiotherapy Oncology Centre "S.Maria" Hospital, Terni
Fabio Trippa, MD
Study Director
Radiotherapy Oncology Centre "S.Maria" Hospital, Terni
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported