Cancer, Locally Advanced, Locally Advanced Carcinoma, Locally Advanced Solid Tumor, Metastatic Cancer
Conditions
Keywords
Radiation, Radiotherapy, Bulky, Spatial fractionation, Lattice therapy, Palliative, Palliation
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.
Interventions
RADIATIONLattice therapy (LRT)
5 Fractions LRT
Sponsors
University of Cincinnati
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Contacts
CONTACTUCCC Clinical Trials Office
CONTACTAndrew Frankart, MD
Outcome results
None listed