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

NCT06207292 | Unknown

• 1 other identifier: SABR-oligoM NSCLC 810
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

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; Non-Small Cell Squamous Lung Cancer; Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor; Synchronous Metastases; Metachronous Metastasis

Keywords

oligo-M NSCLC; SAbR

Outcome Measures

Primary Outcomes (3)

• new systemic therapy-free survival

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

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

• systemic therapy-free survival

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

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

• 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

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

Secondary Outcomes (5)

• progression free survival

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

• overall survival

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

• local control

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

• time to new oligo-metastatic evidence

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

• time to time to poly-metastatic progression not amenable by SABR

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

Study Arms (1)

SABR in oligo-M NSCLC

EXPERIMENTAL

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

Radiation: Stereotactic Ablative Radiotherapy

Interventions

Stereotactic Ablative Radiotherapy RADIATION

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

Also known as: Targeted Therapy; Immunotherapy; Chemotherapy

SABR in oligo-M NSCLC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radiotherapy Oncology Centre "Santa Maria" Hospital: lead
• Paola Anselmo,MD: collaborator
• Michelina Casale,PhD: collaborator
• Fabio Trippa,MD: collaborator

Study Sites (1)

Radiotherapy Oncology Centre "S.Maria" Hospital

Terni, TR, 05100, Italy

RECRUITING

Related Publications (17)

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  PMID: 31908301 RESULT

• 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.

  PMID: 32388150 RESULT

• 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.

  PMID: 30982687 RESULT

• 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.

  PMID: 32484754 RESULT

• 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.

  PMID: 27441744 RESULT

• 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.

  PMID: 28973074 RESULT

• 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.

  PMID: 31067138 RESULT

• 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.

  PMID: 35094066 RESULT

• 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.

  PMID: 37105304 RESULT

• 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.

  PMID: 36288758 RESULT

• 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.

  PMID: 35243022 RESULT

• 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.

  PMID: 37451182 RESULT

• 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.

  PMID: 34430382 RESULT

• 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.

  PMID: 37435562 RESULT

• 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.

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• Arcidiacono F, Aristei C, Marchionni A, Italiani M, Fulcheri CPL, Saldi S, Casale M, Ingrosso G, Anselmo P, Maranzano E. Stereotactic body radiotherapy for adrenal oligometastasis in lung cancer patients. Br J Radiol. 2020 Nov 1;93(1115):20200645. doi: 10.1259/bjr.20200645. Epub 2020 Sep 2.

  PMID: 32822540 RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Immunotherapy; Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Study Officials

• Fabio Arcidiacono, MD

  Radiotherapy Oncology Centre "S.Maria" Hospital, Terni

  PRINCIPAL INVESTIGATOR

• Paola Anselmo, MD

  Radiotherapy Oncology Centre "S.Maria" Hospital, Terni

  PRINCIPAL INVESTIGATOR

• Michelina Casale, PhD

  Radiotherapy Oncology Centre "S.Maria" Hospital, Terni

  PRINCIPAL INVESTIGATOR

• Fabio Trippa, MD

  Radiotherapy Oncology Centre "S.Maria" Hospital, Terni

  STUDY DIRECTOR

Central Study Contacts

Fabio Arcidiacono, MD

CONTACT

+390744205729; f.arcidiacono@aospterni.it

Paola Anselmo, MD

CONTACT

+390744205729; p.anselmo@aospterni.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 27, 2023
• First Posted: January 16, 2024
• Study Start: December 1, 2016
• Primary Completion: January 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 16, 2024

Record last verified: 2024-01

Locations

IT (1)