LAttice Radiation Therapy for Large Lesions: Reggio Emilia Single-arm Phase II Trial
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAzienda USL Reggio Emilia - IRCCS
About this 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Lattice radiation therapy
Treatment groups
56 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov