Lattice Radiotherapy for Dose-Escalated Palliation of Bulky Tumors

NCT ID: NCT06416007

Last Updated: 2024-08-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-02
• Study Completion Date: 2027-06-01

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.

Conditions

Cancer; Metastatic Cancer; Locally Advanced; Locally Advanced Solid Tumor; Locally Advanced Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lattice radiation therapy (LRT)

Lattice radiation therapy (LRT) : 5 fractions

Group Type: EXPERIMENTAL

Lattice therapy (LRT)

Intervention Type: RADIATION

5 Fractions LRT

Interventions

Lattice therapy (LRT)

5 Fractions LRT

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Andrew Frankart

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

UCCC Clinical Trials Office

Role: CONTACT

cancer@uchealth.com

513-584-7698

Andrew Frankart, MD

Role: CONTACT

Facility Contacts

Andrew Frankart, MD

Role: primary

Other Identifiers

UCCC-RT-23-01

Identifier Type: -

Identifier Source: org_study_id