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

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This is a prospective, non-randomized, single arm, single institution phase II trial to evaluate the safety and effectiveness of stereotactic ablative radiotherapy (SABR) in oncogene addicted and non-oncogene addicted synchronous and/or metachronous oligo-metastatic (oligoM) non-small cell lung cancer (NSCLC) patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Radiotherapy Oncology Centre S.Maria Hospital
RECRUITING
Terni
Contact Information
Primary
Fabio Arcidiacono, MD
f.arcidiacono@aospterni.it
+390744205729
Backup
Paola Anselmo, MD
p.anselmo@aospterni.it
+390744205729
Time Frame
Start Date: 2016-12
Estimated Completion Date: 2024-12
Participants
Target number of participants: 100
Treatments
Experimental: SABR in oligo-M NSCLC
Synchronous and Metachronous oligo-M NSCLC patients will be enrolled to stereotactic ablative radiotherapy (SABR) of primary tumour (T) and/or regional node(s) (N) and oligo-metastatic site (M) with the aim of maintaining ongoing therapy or delaying delaying the start of systemic therapy
Related Therapeutic Areas
Lung Cancer
Non-Small Cell Lung Cancer (NSCLC)
Sponsors
Collaborators: Michelina Casale,PhD, Paola Anselmo,MD, Fabio Trippa,MD
Leads: Radiotherapy Oncology Centre Santa Maria Hospital

This content was sourced from clinicaltrials.gov

Similar Clinical Trials

ValUe of Screening MRI Brain in Patients With Newly Diagnosed Stage IV Non-oncogene Addicted Non-small Cell Lung CANcer - The VULCAN Trial

ValUe of Screening MRI Brain in Patients With Newly Diagnosed Stage IV Non-oncogene Addicted Non-small Cell Lung CANcer - The VULCAN Trial

Enrollment Status: Recruiting
Publish Date: May 23, 2024
Intervention Type: Diagnostic test
Study Phase: Not Applicable

A Phase II Randomized Controlled Trial of TKI Alone Versus TKI and Local Consolidative Radiation Therapy in Oncogene Driver Mutated Oligo Metastatic Non Small Cell Lung Cancer Patients

A Phase II Randomized Controlled Trial of TKI Alone Versus TKI and Local Consolidative Radiation Therapy in Oncogene Driver Mutated Oligo Metastatic Non Small Cell Lung Cancer Patients

Who is this study for: Patients with oncogene driver mutated oligo metastatic non small cell lung cancer
Enrollment Status: Recruiting
Publish Date: September 10, 2025
Intervention Type: Drug, Radiation
Study Drug: TKI
Study Phase: Phase 2

Exercise in Extended Oncogene Addicted Lung Cancer in Active Treatment: a Randomized Controlled Trial

Exercise in Extended Oncogene Addicted Lung Cancer in Active Treatment: a Randomized Controlled Trial

Enrollment Status: Recruiting
Publish Date: May 31, 2023
Intervention Type: Other
Study Phase: Not Applicable
View All