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NSCLCSTARTNEWERA-OMNCT06207292

Stereotactic Ablative Radiotherapy in Synchronous and Metachronous Oligo-Metastatic Non Small Cell Lung Cancer

A study testing Stereotactic Ablative Radiotherapy in people with NSCLC and NSCLC Stage IV, run by Radiotherapy Oncology Centre "Santa Maria" Hospital at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
NSCLC, NSCLC Stage IV, Oligometastatic Disease
What is being tested?
Stereotactic Ablative Radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteItaly
Study dates
Dec 2016to Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Fabio Arcidiacono, MD contact

+390744205729

f.arcidiacono@aospterni.it

Paola Anselmo, MD contact

+390744205729

p.anselmo@aospterni.it

Italy1 site, 1 recruiting

  • Radiotherapy Oncology Centre "S.Maria" Hospital

    Terni, TR, 05100

    Fabio Arcidiacono, MD, +390744205729, f.arcidiacono@aospterni.it

    Paola Anselmo, MD, +390744205729, p.anselmo@aospterni.it

    Recruiting

Other trials in Italy

About this study

Official title: 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 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.

Read the detailed description

Targeted Therapies and Immunotherapy have fundamentally changed the treatment of metastatic non-small cell lung cancer (NSCLC).

There is an increasing interest in the use of stereotactic ablative radiotherapy (SABR) for oligo-metastatic (oligo-M) NSCLC patients. It is postulated that definitive treatment of the primary as well as regional node/s and oligo-M in these patients may improve their overall survival (OS). Oligo-M is considered an intermediate state between local and poly-metastatic disease and is commonly defined as 1-5 metastatic lesions, in keeping with the recent European Society of Radiotherapy and Oncology (ESTRO) and American Society for Radiation Oncology (ASTRO) consensus.

If discovered within 4-6months of diagnosis, they are termed synchronous oligo-M. Alternatively, should oligo-M develop following definitive treatment of the primary tumour, this is termed metachronous oligo-M.

Multiple clinical trials have demonstrated prolonged survival following SABR treatment to all sites of oligo-M, particularly in NSCLC.

Targeted therapies (TT) and Immunotherapy (IT) have transformed the landscape of NSCLC treatment by improving OS in metastatic setting. However, most SABR trials for oligo-M patients were conducted in the pre-TT and pre-IT era. How SABR and TT or IT should be integrated in the treatment of oligo-M NSCLC therefore remains an active area of investigation.

Oligo-M is considered a clinically distinct from poly-metastatic disease, presenting a unique therapeutic window during which the treatment of all oligo-M may result in long-term disease control and possibly cure in select cases.

SABR offers the advantages of being non-invasive, safe, and well-tolerated, even by frail patients. It ablates multiple targets simultaneously achieving good rates of local control. The objectives of treating oligo-M using SABR include:

  1. ablating all sites of visible disease to reduce tumor burden
  2. preventing progression to a poly-metastatic disease state
  3. relieving morbidity associated with metastases without a decline in quality of life (QoL)
  4. delaying the start of systemic therapy

Reasons to support SABR in oligo-M NSCLC:

  1. Systemic treatment alone does not eradicate the presence of all oligo-M disease. SABR may improve local control at the sites of oligo-M decreasing the risk of poly-metastatic widespread by reducing the burden of proliferative malignant cells
  2. SABR is a histology-agnostic ablative technique which can eradicate systemic therapy-resistant disease. So, SABR optimizes local control at the sites of oligo-M, thereby delaying the need to start a new systemic therapy or eliminating the morbidity and potential mortality associated with local and eventually distant progression of disease.
  • Targeted therapies (TT) or Immunotherapy (IT) (chemotherapy) will be combined with early SABR of all cancer sites in patients with synchronous oligo-M NSCLC: primary tumour (T), regional node/s (N) and oligo-metastases (M). Eradication of all macroscopic cancer sites at the time of primary diagnosis by combined modality treatment is expected to decrease the risk of resistance development with only microscopic disease potentially remaining. This will result in improvement of progression free survival (PFS), QoL, delayed change of therapy and OS without added high-grade (>G3) toxicity. Synchronous oligo-M NSCLC patients will be enrolled to SABR and TT or IT.
  • Targeted therapies or Immunotherapy (chemotherapy) will be combined with SABR of all cancer residual sites in patients with oligo-persistence, oligo-progressive or oligo- induced oligo-M NSCLC: primary tumour (T), regional node/s (N) and oligo-M. Eradication of all macroscopic cancer sites at the time of oligo-persistence or oligo- progression by combined modality treatment is expected to delay the initiation of a new systemic therapy. This will result in improvement of PFS and QoL, delayed change of therapy and OS without added high-grade (>G3) toxicity. Metachronous oligo-M NSCLC patients will be enrolled to SABR including maintenance TT or IT.
  • Patients unfit for systemic therapy with synchronous or metachronous oligo-M NSCLC will be enrolled to receive SABR alone in all sites of disease. Eradication of all macroscopic cancer sites is expected to delay the widespread and/or symptomatic disease. This will result in improvement of OS and QoL without added high-grade (>G3) toxicity.
Being tested
Stereotactic Ablative Radiotherapy
Keywords
oligo-M NSCLC, SAbR
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stereotactic Ablative RadiotherapyRadiation

    Also called Targeted Therapy; Immunotherapy; Chemotherapy

    The prescribed dose of stereotactic ablative radiotherapy (SABR) will be chosen based on the target to be treated and its proximity to organs at risk(s):

    Lung-peripheral 33-45 Gy/ 3 fractions

    Lung-central/ultra-central 35-60 Gy/5 fractions

    Mediastinal/supraclavicular node 35-45 Gy/5 fractions

    Liver 45-54 Gy/3 fractions; 50-65 Gy/5 fractions

    Bone non-spine 30-36 Gy/3 fractions; 35-50 Gy/5 fractions

    Bone spine 30-33 Gy/3 fractions (SIB); 35-40 Gy/ 5 fractions (SIB)

    Abdominal-pelvic node 33-39 Gy/ 3 fractions; 35-50 Gy/5 fractions

    Adrenal gland 30-42 Gy/3 fractions; 35-50 Gy/5 fractions

Study groups in NCT06207292
Study groupRoleWhat they receive
SABR in oligo-M NSCLCExperimentalSynchronous 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
Receives: Radiation: Stereotactic Ablative Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. new systemic therapy-free survival

    time that the patient maintains the same therapy without the need to change it

    Measured: 6 months; 1 year, 2 years, 3 years and 5 years

  2. systemic therapy-free survival

    time in which the patient does not need to start systemic therapy (for patients without active systemic therapy)

    Measured: 6 months; 1 year, 2 years, 3 years and 5 years

  3. proportion of patients experiencing grade 3 or higher toxicities

    SABR will be considered safe if no grade (G) or higher toxicities appears. Toxicity will be evaluated according CTCAE scale

    Measured: 6 months; 1 year, 2 years, 3 years and 5 years

Secondary outcomes (5)

  1. progression free survival

    The interval between treatment and radiological evidence of any progression

    Measured: 6 months; 1 year, 2 years, 3 years and 5 years

  2. overall survival

    The interval between treatment and death

    Measured: 6 months; 1 year, 2 years, 3 years and 5 years

  3. local control

    A lack of progression (i.e. any response and stable disease) of the treated volume

    Measured: 6 months; 1 year, 2 years, 3 years and 5 years

  4. time to new oligo-metastatic evidence

    The interval between treatment and radiological evidence of new oligo-metastatic progression amenable by SABR

    Measured: 6 months; 1 year, 2 years, 3 years and 5 years

  5. time to time to poly-metastatic progression not amenable by SABR

    The interval between treatment and radiological evidence of poly-metastatic progression not amenable by SABR

    Measured: 6 months; 1 year, 2 years, 3 years and 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2024
  2. Study startDec 2016
  3. Primary completionJan 2024
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06207292
Sponsor's protocol ID
SABR-oligoM NSCLC 810
Acronym
STARTNEWERA-OM
Status last verified
Jan 2024
First submitted
27 Dec 2023
Last updated
16 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Guckenberger M, Lievens Y, Bouma AB, Collette L, Dekker A, deSouza NM, Dingemans AC, Fournier B, Hurkmans C, Lecouvet FE, Meattini I, Mendez Romero A, Ricardi U, Russell NS, Schanne DH, Scorsetti M, Tombal B, Verellen D, Verfaillie C, Ost P. Characterisation and classification of oligometastatic disease: a European Society for Radiotherapy and Oncology and European Organisation for Research and Treatment of Cancer consensus recommendation. Lancet Oncol. 2020 Jan;21(1):e18-e28. doi: 10.1016/S1470-2045(19)30718-1.

    PubMed 31908301

  • Lievens Y, Guckenberger M, Gomez D, Hoyer M, Iyengar P, Kindts I, Mendez Romero A, Nevens D, Palma D, Park C, Ricardi U, Scorsetti M, Yu J, Woodward WA. Defining oligometastatic disease from a radiation oncology perspective: An ESTRO-ASTRO consensus document. Radiother Oncol. 2020 Jul;148:157-166. doi: 10.1016/j.radonc.2020.04.003. Epub 2020 Apr 22.

    PubMed 32388150

  • Palma DA, Olson R, Harrow S, Gaede S, Louie AV, Haasbeek C, Mulroy L, Lock M, Rodrigues GB, Yaremko BP, Schellenberg D, Ahmad B, Griffioen G, Senthi S, Swaminath A, Kopek N, Liu M, Moore K, Currie S, Bauman GS, Warner A, Senan S. Stereotactic ablative radiotherapy versus standard of care palliative treatment in patients with oligometastatic cancers (SABR-COMET): a randomised, phase 2, open-label trial. Lancet. 2019 May 18;393(10185):2051-2058. doi: 10.1016/S0140-6736(18)32487-5. Epub 2019 Apr 11.

    PubMed 30982687

  • Palma DA, Olson R, Harrow S, Gaede S, Louie AV, Haasbeek C, Mulroy L, Lock M, Rodrigues GB, Yaremko BP, Schellenberg D, Ahmad B, Senthi S, Swaminath A, Kopek N, Liu M, Moore K, Currie S, Schlijper R, Bauman GS, Laba J, Qu XM, Warner A, Senan S. Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of Oligometastatic Cancers: Long-Term Results of the SABR-COMET Phase II Randomized Trial. J Clin Oncol. 2020 Sep 1;38(25):2830-2838. doi: 10.1200/JCO.20.00818. Epub 2020 Jun 2.

    PubMed 32484754

  • Correa RJ, Salama JK, Milano MT, Palma DA. Stereotactic Body Radiotherapy for Oligometastasis: Opportunities for Biology to Guide Clinical Management. Cancer J. 2016 Jul-Aug;22(4):247-56. doi: 10.1097/PPO.0000000000000202.

    PubMed 27441744

  • Iyengar P, Wardak Z, Gerber DE, Tumati V, Ahn C, Hughes RS, Dowell JE, Cheedella N, Nedzi L, Westover KD, Pulipparacharuvil S, Choy H, Timmerman RD. Consolidative Radiotherapy for Limited Metastatic Non-Small-Cell Lung Cancer: A Phase 2 Randomized Clinical Trial. JAMA Oncol. 2018 Jan 11;4(1):e173501. doi: 10.1001/jamaoncol.2017.3501. Epub 2018 Jan 11.

    PubMed 28973074

  • Gomez DR, Tang C, Zhang J, Blumenschein GR Jr, Hernandez M, Lee JJ, Ye R, Palma DA, Louie AV, Camidge DR, Doebele RC, Skoulidis F, Gaspar LE, Welsh JW, Gibbons DL, Karam JA, Kavanagh BD, Tsao AS, Sepesi B, Swisher SG, Heymach JV. Local Consolidative Therapy Vs. Maintenance Therapy or Observation for Patients With Oligometastatic Non-Small-Cell Lung Cancer: Long-Term Results of a Multi-Institutional, Phase II, Randomized Study. J Clin Oncol. 2019 Jun 20;37(18):1558-1565. doi: 10.1200/JCO.19.00201. Epub 2019 May 8.

    PubMed 31067138

  • Wang XS, Bai YF, Verma V, Yu RL, Tian W, Ao R, Deng Y, Zhu XQ, Liu H, Pan HX, Yang L, Bai HS, Luo X, Guo Y, Zhou MX, Sun YM, Zhang ZC, Li SM, Cheng X, Tan BX, Han LF, Liu YY, Zhang K, Zeng FX, Jia L, Hao XB, Wang YY, Feng G, Xie K, Lu Y, Zeng M. Randomized Trial of First-Line Tyrosine Kinase Inhibitor With or Without Radiotherapy for Synchronous Oligometastatic EGFR-Mutated Non-Small Cell Lung Cancer. J Natl Cancer Inst. 2023 Jun 8;115(6):742-748. doi: 10.1093/jnci/djac015.

    PubMed 35094066

  • Peng P, Gong J, Zhang Y, Zhou S, Li Y, Han G, Meng R, Chen Y, Yang M, Shen Q, Chu Q, Xia S, Zhang P, Zhang L, Chen Y, Zhang L. EGFR-TKIs plus stereotactic body radiation therapy (SBRT) for stage IV Non-small cell lung cancer (NSCLC): A prospective, multicenter, randomized, controlled phase II study. Radiother Oncol. 2023 Jul;184:109681. doi: 10.1016/j.radonc.2023.109681. Epub 2023 Apr 25.

    PubMed 37105304

  • Arcidiacono F, Anselmo P, Casale M, Zannori C, Ragusa M, Mancioli F, Marchetti G, Loreti F, Italiani M, Bracarda S, Maranzano E, Trippa F. STereotactic Ablative RadioTherapy in NEWly Diagnosed and Recurrent Locally Advanced Non-Small Cell Lung Cancer Patients Unfit for ConcurrEnt RAdio-Chemotherapy: Early Analysis of the START-NEW-ERA Non-Randomised Phase II Trial. Int J Radiat Oncol Biol Phys. 2023 Mar 15;115(4):886-896. doi: 10.1016/j.ijrobp.2022.10.025. Epub 2022 Oct 24.

    PubMed 36288758

  • Bahig H, Tonneau M, Blais N, Wong P, Filion E, Campeau MP, Vu T, Al-Saleh A, Tehfe M, Florescu M, Roberge D, Masucci L, Richard C, Menard C, Routy B. Stereotactic Ablative Radiotherapy for oligo-progressive disease refractory to systemic therapy in Non-Small Cell Lung Cancer: A registry-based phase II randomized trial (SUPPRESS-NSCLC). Clin Transl Radiat Oncol. 2022 Jan 5;33:115-119. doi: 10.1016/j.ctro.2021.12.008. eCollection 2022 Mar.

    PubMed 35243022

  • Jongbloed M, Bartolomeo V, Steens M, Dursun S, van de Lisdonk T, De Ruysscher DKM, Hendriks LEL. Treatment outcome of patients with synchronous oligometastatic non-small cell lung cancer in the immunotherapy era: Analysis of a real-life intention-to-treat population. Eur J Cancer. 2023 Sep;190:112947. doi: 10.1016/j.ejca.2023.112947. Epub 2023 Jun 20.

    PubMed 37451182

  • Remon J, Menis J, Levy A, De Ruysscher DKM, Hendriks LEL. How to optimize the incorporation of immunotherapy in trials for oligometastatic non-small cell lung cancer: a narrative review. Transl Lung Cancer Res. 2021 Jul;10(7):3486-3502. doi: 10.21037/tlcr-20-1065.

    PubMed 34430382

  • Zayed S, Louie AV, Breadner DA, Palma DA, Correa RJM. Radiation and immune checkpoint inhibitors in the treatment of oligometastatic non-small-cell lung cancer: a practical review of rationale, recent data, and research questions. Ther Adv Med Oncol. 2023 Jul 8;15:17588359231183668. doi: 10.1177/17588359231183668. eCollection 2023.

    PubMed 37435562

  • Baydoun A, Lee VL, Biswas T. Oligometastatic Non-Small Cell Lung Cancer: A Practical Review of Prospective Trials. Cancers (Basel). 2022 Oct 29;14(21):5339. doi: 10.3390/cancers14215339.

    PubMed 36358757

Questions about this trial

What is this clinical trial studying?

A study testing Stereotactic Ablative Radiotherapy in people with NSCLC and NSCLC Stage IV, run by Radiotherapy Oncology Centre "Santa Maria" Hospital at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Fabio Arcidiacono, MD (+390744205729, f.arcidiacono@aospterni.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

new systemic therapy-free survival (time frame: 6 months; 1 year, 2 years, 3 years and 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06207292, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024.

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