NCT07000162

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for phase_2 cancer

Timeline
24mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
May 2025May 2028

First Submitted

Initial submission to the registry

May 23, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

May 26, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 2, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

August 29, 2025

Status Verified

June 1, 2025

Enrollment Period

1.9 years

First QC Date

May 23, 2025

Last Update Submit

August 28, 2025

Conditions

CancerPalliative Radiotherapy

Keywords

Lattice radiotherapyLattice radiation therapySpatially Fractionated Radiation TherapyLarge cancersPalliative radiotherapy

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate

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

    At 3 months following completion of Lattice radiation therapy

Secondary Outcomes (4)

  • Local Control

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

  • Treatment-related toxicity

    1 year following completion of Lattice radiation therapy.

  • Patient-reported outcomes (Quality of life)

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

  • Patient-reported outcomes (Quality of life)

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

Other Outcomes (1)

  • Immunomodulatory effects of Lattice Radiation Therapy (LRT)

    7-14 days after the end of the treatment

Study Arms (1)

Lattice radiation therapy

EXPERIMENTAL

Radiation: 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.

Radiation: Lattice radiation therapy

Interventions

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).

Lattice radiation therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda USL IRCCS di Reggio Emilia

Reggio Emilia, Italy, 42123, Italy

RECRUITING

Related Publications (9)

  • 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.

    PMID: 31768424BACKGROUND

  • 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.

    PMID: 33064814BACKGROUND

  • 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.

    PMID: 34195486BACKGROUND

  • 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.

    PMID: 36590825BACKGROUND

  • 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.

    PMID: 34875286BACKGROUND

  • 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.

    PMID: 24246848BACKGROUND

  • 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.

    PMID: 33142765BACKGROUND

  • 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.

    PMID: 25036982BACKGROUND

  • 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.

    PMID: 34209192BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Cinzia Iotti, MD

    Azienda USL - IRCCS di Reggio Emilia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Federico Iori, MD

CONTACT

+39 0522 296261federico.iori@ausl.re.it

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2025

First Posted

June 2, 2025

Study Start

May 26, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2028

Last Updated

August 29, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)