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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lattice radiation therapy (LRT) | Experimental | Lattice radiation therapy (LRT) : 5 fractions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lattice therapy (LRT) | Radiation | 5 Fractions LRT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | To evaluate the efficacy of lattice therapy in patients with bulky tumors, as measured by objective response rate (ORR) at 60 days post-treatment. | 60 days post treatment |
| Adverse Events | To characterize the safety profile and adverse events (AEs) of lattice therapy. | Up to 60 days post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | To assess overall survival (OS) following lattice therapy. Overall survival will be assessed via review of medical and vital records. | 12 months post treatment |
| Patient-reported Quality of Life |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of Lattice Therapy on Systemic Immune Anti-tumor Responses via analysis of peripheral blood samples. | Blood will be collected pre-treatment, after the last lattice fraction, and at 5 days post-lattice therapy for analysis via flow cytometry. Differences in immune anti-tumor responses be assessed between timepoints/tumor types. Increased immune anti-tumor responses after therapy compared to baseline are anticipated. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| UCCC Clinical Trials Office | Contact | 513-584-7698 | cancer@uchealth.com | |
| Andrew Frankart, MD | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati Medical Center | Recruiting | Cincinnati | Ohio | 45219 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
| 60 days post treatment |
| Up to 5 days post-treatment |