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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Lattice radiation therapy
RadiationA 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).
Treatment groups
56 Participants
are divided into 1 treatment groupGroup A: Lattice radiation therapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective Response Rate
Percentage of patients with complete and partial response according to RECIST1.1 criteria
Time frame
At 3 months following completion of Lattice radiation therapySecondary outcomes
1
Local Control
Percentage of patients with complete response, partial response, and stable disease according to RECIST1.1 criteria
Time frame
At 3, 6,9, and 12 months following completion of Lattice radiation therapy.2
Treatment-related toxicity
Percentage of patients with treatment-related adverse events measured by CTCAE version 5.0
Time frame
1 year following completion of Lattice radiation therapy.3
Patient-reported outcomes (Quality of life)
Scores modification compared to baseline at questionnaire EORTC QLQ-C15-PAL (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 15 - Palliative care version), a 15-item scale with scores ranging from 0 to 100. Higher scores on functional and global health status scales indicate better quality of life, while higher scores on symptom scales indicate worse symptom burden.
Time frame
2 weeks, 30 days, 60 days, and 90 days, 6 months, 9 months, 1 year4
Patient-reported outcomes (Quality of life)
Scores modification compared to baseline at questionnaire PRO-CTCAE (Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events), a patient-reported outcome measure developed by the U.S. National Cancer Institute. Each item is scored on a 5-point scale (range: 0-4), where higher scores indicate greater symptom frequency, severity, or interference with daily activities.
Time frame
2 weeks, 30 days, 60 days, and 90 days, 6 months, 9 months, 1 yearOther outcomes
1
Immunomodulatory effects of Lattice Radiation Therapy (LRT)
Modification compared to baseline of immune cells through cell immunophenotyping and immune-related circulating factors possibly associated with LRT compared to baseline (Exploratory Outcome)
Time frame
7-14 days after the end of the treatmentSponsors and contacts
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Source ClinicalTrials.gov