Lattice Radiotherapy for Dose-Escalated Palliation of Bulky Tumors
- Conditions
- Metastatic CancerLocally AdvancedCancerLocally Advanced Solid TumorLocally Advanced Carcinoma
- Interventions
- Radiation: Lattice therapy (LRT)
- Registration Number
- NCT06416007
- Lead Sponsor
- University of Cincinnati
- Brief Summary
The purpose of this research study is to determine if lattice radiation therapy (LRT) will provide better treatment for bulky (large) tumors than current standard of care radiotherapy.
- Detailed Description
This will be a single-institution, single-arm Phase II trial with an anticipated total of 37 patients enrolled. Treatment will consist of 5 fractions of lattice radiation therapy delivered every other day. The primary endpoints will include the efficacy of lattice therapy as evaluated by ORR (CR or PR per RECIST criteria) at 60 days (2 months) post-treatment and safety. Toxicity will be evaluated at day 5 (+/- 2 days), day 15 (+/- 5 days), day 30 (+/- 5 days), and day 60 (+/- 7 days) post-completion of lattice therapy. This study will also include a translational analysis of the impact of lattice therapy on systemic immune responses.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 37
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lattice radiation therapy (LRT) Lattice therapy (LRT) Lattice radiation therapy (LRT) : 5 fractions
- Primary Outcome Measures
Name Time Method Overall Response Rate 60 days post treatment To evaluate the efficacy of lattice therapy in patients with bulky tumors, as measured by objective response rate (ORR) at 60 days post-treatment.
Adverse Events Up to 60 days post-treatment To characterize the safety profile and adverse events (AEs) of lattice therapy.
- Secondary Outcome Measures
Name Time Method Patient-reported Quality of Life 60 days post treatment To determine patient-reported quality of life outcomes after lattice therapy via the Functional Assessment of Cancer Therapy - General - 7 Item Version (FACT-G7) tool as a measure of global quality of life. This is measured on 5 point Likert-type scale ranging from 0-4. Higher scores reflect better QOL.
Overall Survival 12 months post treatment To assess overall survival (OS) following lattice therapy. Overall survival will be assessed via review of medical and vital records.
Trial Locations
- Locations (1)
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States