Cancer, Palliative Radiotherapy
Conditions
Keywords
Lattice radiotherapy, Lattice radiation therapy, Spatially Fractionated Radiation Therapy, Large cancers, Palliative radiotherapy
Brief 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.
Interventions
RADIATIONLattice 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).
Sponsors
Azienda USL Reggio Emilia - IRCCS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local Control | At 3, 6,9, and 12 months following completion of Lattice radiation therapy. | Percentage of patients with complete response, partial response, and stable disease according to RECIST1.1 criteria |
| Treatment-related toxicity | 1 year following completion of Lattice radiation therapy. | Percentage of patients with treatment-related adverse events measured by CTCAE version 5.0 |
| Patient-reported outcomes (Quality of life) | 2 weeks, 30 days, 60 days, and 90 days, 6 months, 9 months, 1 year | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Immunomodulatory effects of Lattice Radiation Therapy (LRT) | 7-14 days after the end of the treatment | Modification compared to baseline of immune cells through cell immunophenotyping and immune-related circulating factors possibly associated with LRT compared to baseline (Exploratory Outcome) |
Countries
Italy
Contacts
Primary ContactFederico Iori, MD
Outcome results
None listed