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OncoMatch/Clinical Trials/NCT07000162

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

Is NCT07000162 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies non-drug interventions for cancer.

Phase 2RecruitingAzienda USL Reggio Emilia - IRCCSNCT07000162Data as of May 2026

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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Extracted eligibility criteria

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Cannot have received: high-dose radiotherapy

Exception: if the dose overlap is ≤ 10 Gy and is determined safe by the treating physician

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.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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