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NCT Number: NCT07000162

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

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Key information

Conditions

Cancer Neoplasms Palliative Radiotherapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Azienda USL IRCCS di Reggio Emilia

Reggio Emilia, Italy, 42123

Location status: Recruiting

Location contact

Cinzia Iotti, MD

PRINCIPAL_INVESTIGATOR

Federico Iori, MD

CONTACT

[email protected]

+39 0522 296261

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Lattice 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.

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 outcomes

  1. Objective Response Rate

    Time frame: At 3 months following completion of Lattice radiation therapy

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

Secondary outcomes

  1. Local Control

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

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

  2. Treatment-related toxicity

    Time frame: 1 year following completion of Lattice radiation therapy.

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

  3. Patient-reported outcomes (Quality of life)

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

    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.

  4. Patient-reported outcomes (Quality of life)

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

    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.

Other outcomes

  1. Immunomodulatory effects of Lattice Radiation Therapy (LRT)

    Time frame: 7-14 days after the end of the treatment

    Modification compared to baseline of immune cells through cell immunophenotyping and immune-related circulating factors possibly associated with LRT compared to baseline (Exploratory Outcome)

Study contacts

Contact information is provided by the study sponsor or research team.

Federico Iori, MD

CONTACT

[email protected]

+39 0522 296261

Sponsors and collaborators

Lead sponsor

Azienda USL Reggio Emilia - IRCCS

Other Gov

Registry information

Official study title

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

Acronym: LART

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jun 2, 2025
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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