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Clinical Trial NCT07000162 (LART) for Cancer, Palliative Radiotherapy is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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LAttice Radiation Therapy for Large Lesions: Reggio Emilia Single-arm Phase II Trial (LART) Phase 2 56

Recruiting
Clinical Trial NCT07000162 (LART) is designed to study Treatment for Cancer, Palliative Radiotherapy. It is a Phase 2 interventional study that is recruiting, having started on May 26, 2025, with plans to enroll 56 participants. Led by Azienda USL Reggio Emilia - IRCCS, it is expected to complete by May 1, 2028. The latest data from ClinicalTrials.gov was last updated on August 29, 2025.
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...Show More
Official Title

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

Conditions
CancerPalliative Radiotherapy
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • LART
  • 5/2025/SPER/IRCCSRE
NCT ID Number
NCT07000162
Start Date (Actual)
2025-05-26
Last Update Posted
2025-08-29
Completion Date (Estimated)
2028-05-01
Enrollment (Estimated)
56
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Keywords
Lattice radiotherapy
Lattice radiation therapy
Spatially Fractionated Radiation Therapy
Large cancers
Palliative radiotherapy
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalLattice radiation therapy
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.
Lattice radiation therapy
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).
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Local Control
Percentage of patients with complete response, partial response, and stable disease according to RECIST1.1 criteria
At 3, 6,9, and 12 months following completion of Lattice radiation therapy.
Treatment-related toxicity
Percentage of patients with treatment-related adverse events measured by CTCAE version 5.0
1 year following completion of Lattice radiation therapy.
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.
2 weeks, 30 days, 60 days, and 90 days, 6 months, 9 months, 1 year
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.
2 weeks, 30 days, 60 days, and 90 days, 6 months, 9 months, 1 year
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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

  • 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
Azienda USL Reggio Emilia - IRCCS logoAzienda USL Reggio Emilia - IRCCS
Study Central Contact
Contact: Federico Iori, MD, +39 0522 296261, [email protected]
1 Study Locations in 1 Countries

Italy

Azienda USL IRCCS di Reggio Emilia, Reggio Emilia, Italy, 42123, Italy
Federico Iori, MD, Contact, +39 0522 296261, [email protected]
Cinzia Iotti, MD, Principal Investigator
Recruiting