LAttice Radiation Therapy for Large Lesions: Reggio Emilia Single-arm Phase II Trial
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| Azienda USL IRCCS di Reggio Emilia | Reggio Emilia | Italy | Recruiting |
More Azienda USL Reggio Emilia - IRCCS trials in Italy
Other trials for the same condition
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