NCT07000162

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Azienda USL Reggio Emilia - IRCCS · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer
• Palliative Radiotherapy

Interventions

Type	Name	Description
RADIATION	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).

Timeline

• Start date: 2025-05-26
• Primary completion: 2027-05-01
• Completion: 2028-05-01
• First posted: 2025-06-02
• Last updated: 2025-08-29

Locations

1 site across 1 country: Italy