A Phase 2 Study of Lattice Radiotherapy for Dose-Escalated Palliation of Bulky Tumors
University of Cincinnati
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.
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 latt…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- RadiationLattice therapy (LRT)
5 Fractions LRT
Location
- University of Cincinnati Medical CenterCincinnati, Ohio