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Trial Title:
Lattice Radiotherapy for Dose-Escalated Palliation of Bulky Tumors
NCT ID:
NCT06416007
Condition:
Cancer
Metastatic Cancer
Locally Advanced
Locally Advanced Solid Tumor
Locally Advanced Carcinoma
Conditions: Official terms:
Neoplasm Metastasis
Conditions: Keywords:
Radiation
Radiotherapy
Bulky
Spatial fractionation
Lattice therapy
Palliative
Palliation
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Lattice therapy (LRT)
Description:
5 Fractions LRT
Arm group label:
Lattice radiation therapy (LRT)
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Cincinnati Medical Center
Address:
City:
Cincinnati
Zip:
45219
Country:
United States
Status:
Recruiting
Contact:
Last name:
Andrew Frankart, MD
Start date:
August 2, 2024
Completion date:
June 1, 2027
Lead sponsor:
Agency:
University of Cincinnati
Agency class:
Other
Source:
University of Cincinnati
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06416007
