NCT06416007

Lattice Radiotherapy for Dose-Escalated Palliation of Bulky Tumors

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (estimated)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
RADIATION	Lattice therapy (LRT)	5 Fractions LRT

Timeline

• Start date: 2024-08-02
• Primary completion: 2027-01-01
• Completion: 2027-06-01
• First posted: 2024-05-16
• Last updated: 2024-08-22

Locations

1 site across 1 country: United States