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

Phase 2RecruitingNCT07000162

Azienda USL Reggio Emilia - IRCCS56 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cancer Palliative Radiotherapy

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. * Life expectancy \> 6 months. * At least one measurable non-brain site of disease with a diameter ≥ 4.5 cm, in any direction * Ability to understand and willingness to sign the written informed consent document (or that of legally authorized representative, if applicable). Reproductive Status * Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of LRT. * Women must not be breastfeeding. * WOCBP must agree to follow instructions for method(s) of contraception for the duration of LRT plus 30 days (duration of ovulatory cycle). * Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of LRT plus 90 days (duration of sperm turnover). * Investigators shall counsel WOCBP patients and male patients who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy Exclusion Criteria: * 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

Outcomes

Primary Outcomes

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 therapy

Secondary Outcomes

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.

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.

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 year