Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID06416007

A Phase 2 Study of Lattice Radiotherapy for Dose-Escalated Palliation of Bulky Tumors

Led by University of Cincinnati · Updated on 2026-05-04

37

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating whether lattice radiation therapy (LRT) can provide better treatment for large tumors compared to the current standard radiotherapy. This is a Phase II trial conducted at a single institution, focusing on patients with solid tumor malignancies that require radiation treatment. The study also explores how lattice therapy may affect systemic immune responses. Participants will receive lattice radiation therapy consisting of 5 treatment sessions (fractions) delivered every other day. This single-arm trial plans to enroll a total of 37 patients. The primary goal includes evaluating the treatment's effectiveness by measuring tumor response 60 days after treatment and assessing safety through monitoring side effects at multiple time points up to 60 days post-therapy. During the study, participants will undergo assessments at days 5, 15, 30, and 60 after completing therapy to check for any adverse effects. Researchers will also collect data on overall survival up to 12 months post-treatment and gather patient-reported quality of life information at 60 days. Participants will be monitored closely throughout the trial, which emphasizes both treatment outcomes and safety.

CONDITIONS

Brief Title

Lattice Radiotherapy for Dose-Escalated Palliation of Bulky Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Solid tumor malignancy requiring radiation treatment
  • Measurable disease present
  • Target tumor amenable to lattice therapy planning and immobilization if applicable
  • Age 18 years or older
  • ECOG Performance status of 2 or less
  • Life expectancy greater than 3 months
  • Agreement to use birth control or abstinence before and 30 days after treatment if of child-bearing potential
  • Ability to understand and willing to sign informed consent
Not Eligible

You will not qualify if you...

  • Receiving cytotoxic chemotherapy or radiosensitizing agents within 5 days before or after lattice therapy
  • Hematologic malignancies like lymphoma or leukemia, or CNS malignancies
  • History of conditions that increase radiation toxicity risk
  • Known contraindications to radiation therapy
  • Uncontrolled intercurrent illness
  • Pregnant women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 2 weeks

Participants receive lattice radiation therapy consisting of 5 fractions delivered every other day.

5 treatment visits

Follow-up

Duration - Up to 60 days post-treatment

Participants are monitored for safety and response after completing lattice therapy, including assessments at day 5, 15, 30, and 60 post-treatment.

4 follow-up visits

Trial Site Locations

Total: 1 location

1

University of Cincinnati Medical Center

Cincinnati, Ohio, United States, 45219

Actively Recruiting

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Research Team

U

UCCC Clinical Trials Office

A

Andrew Frankart, MD

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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