Lattice Radiotherapy for Dose-Escalated Palliation of Bulky Tumors

Cancer Clinical Trial

Official title:

A Phase 2 Study of Lattice Radiotherapy for Dose-Escalated Palliation of Bulky Tumors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06416007
• Other study ID #: UCCC-RT-23-01
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 1, 2024
• Est. completion date: June 1, 2027

Study information

• Verified date: May 2024
• Source: University of Cincinnati
• Contact: UCCC Clinical Trials Office
• Phone: 513-584-7698
• Email: cancer[@]uchealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 lattice therapy on systemic immune responses.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 37
• Est. completion date: June 1, 2027
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Locally Advanced
• Locally Advanced Solid Tumor
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Radiation:
• Lattice therapy (LRT)
5 Fractions LRT

Locations

Country	Name	City	State
United States	University of Cincinnati Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Up to 5 days post-treatment
Primary	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
Primary	Adverse Events	To characterize the safety profile and adverse events (AEs) of lattice therapy.	Up to 60 days post-treatment
Secondary	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
Secondary	Patient-reported Quality of Life	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