Lattice radiation therapy for large unresectable tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-arm phase 2 study delivers Lattice Radiation Therapy (LRT) in 5 fractions every other day to a baseline of 20 Gy with a simultaneous boost to a median dose of 50 Gy for large non-brain lesions. No concurrent antineoplastic drugs are allowed, and patients are followed at 14, 30, 60, and 90 days after treatment and then every three months up to one year. Tumor response is measured by 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 v5.0), and patient-reported outcomes (EORTC QLQ-C15-PAL and PRO-CTCAE). Exploratory analyses will profile immune cells and circulating immune-related factors before and after LRT to explore possible immunomodulatory effects.

Why it matters

Who can join: the full rules

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

Where it's running

• Azienda USL IRCCS di Reggio Emilia
  Reggio Emilia, Italy, Italy Recruiting

Study contacts

• Principal investigator: Cinzia Iotti, MD — Azienda USL Reggio Emilia - IRCCS
• Study coordinator: Federico Iori, MD
• Email: federico.iori@ausl.re.it
• Phone: +39 0522 296261

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.