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

Launched by AZIENDA USL REGGIO EMILIA - IRCCS · May 23, 2025

Keywords

ClinConnect Summary

The LAttice Radiation Therapy for Large Lesions trial is studying a new approach called Lattice Radiation Therapy (LRT) to treat patients with large cancerous tumors that cannot be surgically removed. This trial aims to see how effective LRT is in relieving symptoms and managing the cancer while also monitoring any side effects. Participants will receive LRT in five treatment sessions, spaced every other day, totaling a specific radiation dose to target the tumors. The trial will follow patients for up to a year to evaluate how well the treatment works and how it affects their quality of life.

To join this study, participants must be at least 18 years old and have a confirmed diagnosis of cancer that is advanced and not treatable with standard therapies. They should have a good performance status, meaning they can carry out daily activities, and must have measurable tumors that are at least 4.5 cm in size. Importantly, the trial is not yet recruiting participants, but it will closely monitor their health and well-being through regular check-ups and scans. Additionally, the study will look into how LRT affects the immune system. Patients interested in participating will need to discuss their reproductive status and follow specific guidelines to prevent pregnancy during the trial.

Gender

ALL

Eligibility criteria

• 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