Clinical trial NCT06416007: Lattice Radiotherapy for Dose-Escalated Palliation of Bulky Tumors
Official title: A Phase 2 Study of Lattice Radiotherapy for Dose-Escalated Palliation of Bulky Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cancer
Metastatic Cancer
Locally Advanced
Locally Advanced Solid Tumor
Locally Advanced Carcinoma
Keywords: Radiation
Radiotherapy
Bulky
Spatial fractionation
Lattice therapy
Palliative
Palliation
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Overall Response Rate
timeFrame: 60 days post treatment
measure: Adverse Events
timeFrame: Up to 60 days post-treatment
Secondary outcomes:
measure: Overall Survival
timeFrame: 12 months post treatment
measure: Patient-reported Quality of Life
timeFrame: 60 days post treatment
Other outcomes:
measure: Impact of Lattice Therapy on Systemic Immune Anti-tumor Responses via analysis of peripheral blood samples.
timeFrame: Up to 5 days post-treatment
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
Study officials:
References: