Lattice Radiotherapy for Dose-Escalated Palliation of Bulky Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lattice therapy (LRT).
- Who it may be relevant to
- Registry conditions: Cancer, Metastatic Cancer, Locally Advanced, Locally Advanced Solid Tumor. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 2 Study of Lattice Radiotherapy for Dose-Escalated Palliation of Bulky Tumors
Overview
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.
Interventions
- Radiation Lattice therapy (LRT)
5 Fractions LRT
Primary outcome measures
- Overall Response Rate [Time frame: 60 days post treatment]
- Adverse Events [Time frame: Up to 60 days post-treatment]
Secondary outcome measures (2)
- Overall Survival [Time frame: 12 months post treatment]
- Patient-reported Quality of Life [Time frame: 60 days post treatment]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Cincinnati Medical Center — Cincinnati
Identifiers
NCT: NCT06416007 · UCCC-RT-23-01