Ireland
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Recruiting Phase 2

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

NCT07000162 · tracked via the Priya Life Science Italy tracker
Phase
Phase 2
Started
2025-05-26
Last updated
2025-08-29

Condition(s) studied

CancerPalliative Radiotherapy

Investigational drug(s) / intervention(s)

Lattice radiation therapy

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).

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Objective Response Rate — At 3 months following completion of Lattice radiation therapy
    Percentage of patients with complete and partial response according to RECIST1.1 criteria

Trial sites (1)

FacilityCityRegionStatus
Azienda USL IRCCS di Reggio Emilia Reggio Emilia Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07000162 on ClinicalTrials.gov ↗ ← All trials in Italy