Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07000162

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

Led by Azienda USL Reggio Emilia - IRCCS · Updated on 2025-08-29

56

Participants Needed

1

Research Sites

153 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older at the time of signing informed consent
  • Histologically or cytologically confirmed cancer diagnosis
  • ECOG Performance Status of 0 to 2
  • Advanced or locally advanced disease not suitable for curative treatment
  • Life expectancy greater than 6 months
  • At least one measurable non-brain tumor lesion with a diameter of 4.5 cm or larger
  • Ability to understand and willingness to sign informed consent
  • Women of childbearing potential must have a negative pregnancy test within 24 hours before treatment
  • Women must not be breastfeeding
  • Women of childbearing potential must agree to use contraception during treatment and for 30 days after
  • Men sexually active with women of childbearing potential must agree to use contraception during treatment and for 90 days after
  • Patients and their partners will receive counseling on pregnancy prevention
Not Eligible

You will not qualify if you...

  • Having another cancer that is progressing or requires active treatment, except basal/squamous skin cancer or in situ cervical cancer
  • Participation in another investigational drug or device study within 2 weeks before starting LRT
  • Prior high-dose radiotherapy overlapping the planned treatment site exceeding 10 Gy or deemed unsafe
  • HIV patients with CD4+ T-cell counts below 350 cells/mcL or a history of AIDS-defining infections within the past 12 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Azienda USL IRCCS di Reggio Emilia

Reggio Emilia, Italy, Italy, 42123

Actively Recruiting

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Research Team

F

Federico Iori, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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