Status:
RECRUITING
LAttice Radiation Therapy for Large Lesions: Reggio Emilia Single-arm Phase II Trial
Lead Sponsor:
Azienda USL Reggio Emilia - IRCCS
Conditions:
Cancer
Palliative Radiotherapy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT07000162
Start Date
May 26 2025
End Date
May 1 2028
Last Update
August 29 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Azienda USL IRCCS di Reggio Emilia
Reggio Emilia, Italy, Italy, 42123