Lattice radiation therapy for treating large tumors
A Phase 2 Study of Lattice Radiotherapy for Dose-Escalated Palliation of Bulky Tumors
This study is testing a new type of radiation therapy called lattice radiation therapy to see if it works better than standard treatment for people with large tumors.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 37 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Cincinnati Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT06416007 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of lattice radiation therapy (LRT) in providing better treatment outcomes for patients with bulky tumors compared to standard radiotherapy. It is a single-institution, single-arm Phase II trial that plans to enroll 37 patients, who will receive LRT in five fractions delivered every other day. The study will assess the overall response rate (ORR) at 60 days post-treatment and monitor safety and toxicity at various intervals. Additionally, a translational analysis will explore the impact of LRT on systemic immune responses.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with solid tumor malignancies that require radiation and have measurable disease.
Not a fit: Patients with hematologic malignancies or those receiving cytotoxic chemotherapy or radiosensitizing agents may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer improved outcomes for patients with large tumors that are difficult to manage with conventional therapies.
How similar studies have performed: While lattice therapy is a novel approach, similar studies have shown promise in enhancing treatment efficacy for bulky tumors.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Solid tumor malignancy with a clinical indication for radiation * Patients must have measurable disease * Target lesion(s) which are amenable to lattice therapy plan * When applicable, target lesion for radiation amenable to immobilization during delivery of radiotherapy * Age ≥18 years. * ECOG Performance status ≤2 * Life expectancy greater than 3 months * Women of child-bearing potential and men must agree to avoid conception via abstinence (ideal) or a method of birth control (e.g., hormonal or barrier method of birth control) prior to study entry and for at least 30 days after completion of lattice therapy administration. * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Patients receiving cytotoxic chemotherapy or known radiosensitizing agents within 5 days before or after lattice therapy. * Patients with hematologic malignancies including lymphoma and leukemia as well as primary or metastatic central nervous system (CNS) malignancies. * Patients with a history of conditions which predispose them to increased radiation toxicity * Patients with known contraindications to radiation therapy * Patients with uncontrolled intercurrent illness * Pregnant women
Where this trial is running
Cincinnati, Ohio
- University of Cincinnati Medical Center — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: UCCC Clinical Trials Office
- Email: cancer@uchealth.com
- Phone: 513-584-7698
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.