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CancerPhase 2LARTNCT07000162

LAttice Radiation Therapy for Large Lesions: Reggio Emilia Single-arm Phase II Trial

A Phase 2 study testing Lattice radiation therapy in people with Cancer and Palliative Radiotherapy, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study evaluates the activity and toxicity of Lattice Radiation Therapy (LRT) in patients with large, unresectable non-brain neoplastic lesions requiring palliative treatment. Eligible patients will 5 fractions LRT, delivered in every other day, to 20 Gy with a simultaneous boost to a minimum median dose of 50 Gy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Palliative Radiotherapy
What is being tested?
Lattice radiation therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteItaly
Study dates
26 May 2025to 1 May 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Age ≥18 on day signing informed consent
  • Histologically or cytologically confirmed cancer.
  • Performance status of 0-2 on the ECOG Performance Scale.
  • Advanced or locally advanced disease, not eligible for curative-intent treatment.
  • Life expectancy > 6 months.
  • At least one measurable non-brain site of disease with a diameter ≥ 4.5 cm, in any direction
Show all 13Show fewer
  • Ability to understand and willingness to sign the written informed consent document (or that of legally authorized representative, if applicable).
  • Reproductive Status
  • Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of LRT.
  • Women must not be breastfeeding.
  • WOCBP must agree to follow instructions for method(s) of contraception for the duration of LRT plus 30 days (duration of ovulatory cycle).
  • Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of LRT plus 90 days (duration of sperm turnover).
  • Investigators shall counsel WOCBP patients and male patients who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy

Who cannot join

  • Additional malignancy that is progressing or requires active treatment. Exceptions include basal and squamous cell carcinoma of the skin or in situ cervical
  • Currently participating in or has participated in a study of an investigational agent or using an investigational device within 2 weeks of the start of LRT.
  • Prior high-dose radiotherapy overlapping with any planned site of protocol radiotherapy, if the dose overlap is > 10 Gy or is determined not safe by the treating physician.
  • HIV patients with CD4+ T-cell counts < 350 cells/mcL or with a history of AIDS-defining opportunistic infection, within the 12 months prior to registration

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Federico Iori, MD contact

+39 0522 296261

federico.iori@ausl.re.it

Italy1 site, 1 recruiting

  • Azienda USL IRCCS di Reggio Emilia

    Reggio Emilia, Italy, 42123

    Federico Iori, MD, +39 0522 296261, federico.iori@ausl.re.it

    Cinzia Iotti, MD

    Recruiting

Other trials in Italy

About this study

Official title: LAttice Radiation Therapy for Large Lesions: Reggio Emilia Single-arm Phase II Trial (LART Trial)

This study evaluates the activity and toxicity of Lattice Radiation Therapy (LRT) in patients with large, unresectable non-brain neoplastic lesions requiring palliative treatment. Eligible patients will 5 fractions LRT, delivered in every other day, to 20 Gy with a simultaneous boost to a minimum median dose of 50 Gy. No concomitant antineoplastic drugs will be allowed. Patients will be followed at 14, 30, 60, and 90 days after treatment, then every 3 months up to 1 year. Tumor response will be assessed using objective response rate (ORR) per RECIST 1.1, with CT scans at 3, 6, 9, and 12 months. Secondary endpoints include local control, toxicity (CTCAE v.5.0), and patient-reported outcomes (PROMs) to assess their quality of life (EORTC QLQ-C15-PAL and PRO-CTCAE). Exploratory objectives will assess the immunomodulatory effects of LRT through immune cell characterization and quantification of immune-related circulating factors before and after treatment.

Being tested
Lattice radiation therapy
Keywords
Lattice radiotherapy, Lattice radiation therapy, Spatially Fractionated Radiation Therapy, Large cancers, Palliative radiotherapy
Medical subject headings
Neoplasms

What participants receive

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

  • Lattice radiation therapyRadiation

    A total dose will be 20 Gy, with a simultaneous boost to selected tumor regions (hot spots) reaching a minimum median dose of 50 Gy.

    Peripheral blood (PB) samples for the immune cell characterization and quantification of immune-related circulating factors will be collected at baseline (pre-therapy) and within 7 -14 days after the end of the treatment (post-therapy).

Study groups in NCT07000162
Study groupRoleWhat they receive
Lattice radiation therapyExperimentalRadiation: A total dose will be 20 Gy, with a simultaneous boost to selected tumor regions (hot spots) reaching a minimum median dose of 50 Gy.
Receives: Radiation: Lattice radiation therapy

What is being measured

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

  1. Objective Response Rate

    Percentage of patients with complete and partial response according to RECIST1.1 criteria

    Measured: At 3 months following completion of Lattice radiation therapy

Secondary outcomes (4)

  1. Local Control

    Percentage of patients with complete response, partial response, and stable disease according to RECIST1.1 criteria

    Measured: At 3, 6,9, and 12 months following completion of Lattice radiation therapy.

  2. Treatment-related toxicity

    Percentage of patients with treatment-related adverse events measured by CTCAE version 5.0

    Measured: 1 year following completion of Lattice radiation therapy.

  3. Patient-reported outcomes (Quality of life)

    Scores modification compared to baseline at questionnaire EORTC QLQ-C15-PAL (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 15 - Palliative care version), a 15-item scale with scores ranging from 0 to 100. Higher scores on functional and global health status scales indicate better quality of life, while higher scores on symptom scales indicate worse symptom burden.

    Measured: 2 weeks, 30 days, 60 days, and 90 days, 6 months, 9 months, 1 year

  4. Patient-reported outcomes (Quality of life)

    Scores modification compared to baseline at questionnaire PRO-CTCAE (Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events), a patient-reported outcome measure developed by the U.S. National Cancer Institute. Each item is scored on a 5-point scale (range: 0-4), where higher scores indicate greater symptom frequency, severity, or interference with daily activities.

    Measured: 2 weeks, 30 days, 60 days, and 90 days, 6 months, 9 months, 1 year

Timeline

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

  1. First posted2 Jun 2025
  2. Study start26 May 2025
  3. Primary completion1 May 2027 (estimated)
  4. Study completion1 May 2028 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07000162
Sponsor's protocol ID
5/2025/SPER/IRCCSRE
Acronym
LART
Status last verified
Jun 2025
First submitted
23 May 2025
Last updated
29 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yan W, Khan MK, Wu X, Simone CB 2nd, Fan J, Gressen E, Zhang X, Limoli CL, Bahig H, Tubin S, Mourad WF. Spatially fractionated radiation therapy: History, present and the future. Clin Transl Radiat Oncol. 2019 Oct 22;20:30-38. doi: 10.1016/j.ctro.2019.10.004. eCollection 2020 Jan. No abstract available.

    PubMed 31768424

  • Wu X, Perez NC, Zheng Y, Li X, Jiang L, Amendola BE, Xu B, Mayr NA, Lu JJ, Hatoum GF, Zhang H, Chang SX, Griffin RJ, Guha C. The Technical and Clinical Implementation of LATTICE Radiation Therapy (LRT). Radiat Res. 2020 Dec 1;194(6):737-746. doi: 10.1667/RADE-20-00066.1.

    PubMed 33064814

  • Duriseti S, Kavanaugh J, Goddu S, Price A, Knutson N, Reynoso F, Michalski J, Mutic S, Robinson C, Spraker MB. Spatially fractionated stereotactic body radiation therapy (Lattice) for large tumors. Adv Radiat Oncol. 2021 Jan 8;6(3):100639. doi: 10.1016/j.adro.2020.100639. eCollection 2021 May-Jun.

    PubMed 34195486

  • Iori F, Cappelli A, D'Angelo E, Cozzi S, Ghersi SF, De Felice F, Ciammella P, Bruni A, Iotti C. Lattice Radiation Therapy in clinical practice: A systematic review. Clin Transl Radiat Oncol. 2022 Dec 20;39:100569. doi: 10.1016/j.ctro.2022.100569. eCollection 2023 Mar.

    PubMed 36590825

  • Duriseti S, Kavanaugh JA, Szymanski J, Huang Y, Basarabescu F, Chaudhuri A, Henke L, Samson P, Lin A, Robinson C, Spraker MB. LITE SABR M1: A phase I trial of Lattice stereotactic body radiotherapy for large tumors. Radiother Oncol. 2022 Feb;167:317-322. doi: 10.1016/j.radonc.2021.11.023. Epub 2021 Dec 4.

    PubMed 34875286

  • Asur R, Butterworth KT, Penagaricano JA, Prise KM, Griffin RJ. High dose bystander effects in spatially fractionated radiation therapy. Cancer Lett. 2015 Jan 1;356(1):52-7. doi: 10.1016/j.canlet.2013.10.032. Epub 2013 Nov 15.

    PubMed 24246848

  • Kumari S, Mukherjee S, Sinha D, Abdisalaam S, Krishnan S, Asaithamby A. Immunomodulatory Effects of Radiotherapy. Int J Mol Sci. 2020 Oct 31;21(21):8151. doi: 10.3390/ijms21218151.

    PubMed 33142765

  • Kanagavelu S, Gupta S, Wu X, Philip S, Wattenberg MM, Hodge JW, Couto MD, Chung KD, Ahmed MM. In vivo effects of lattice radiation therapy on local and distant lung cancer: potential role of immunomodulation. Radiat Res. 2014 Aug;182(2):149-62. doi: 10.1667/RR3819.1. Epub 2014 Jul 18.

    PubMed 25036982

  • Ferini G, Valenti V, Tripoli A, Illari SI, Molino L, Parisi S, Cacciola A, Lillo S, Giuffrida D, Pergolizzi S. Lattice or Oxygen-Guided Radiotherapy: What If They Converge? Possible Future Directions in the Era of Immunotherapy. Cancers (Basel). 2021 Jun 30;13(13):3290. doi: 10.3390/cancers13133290.

    PubMed 34209192

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lattice radiation therapy in people with Cancer and Palliative Radiotherapy, run by Azienda USL Reggio Emilia - IRCCS 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 13 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 29 Aug 2025. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Federico Iori, MD (+39 0522 296261, federico.iori@ausl.re.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: At 3 months following completion of Lattice radiation therapy). 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 NCT07000162, which also lists 9 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 29 Aug 2025.

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