NCT06477692

Invert-Prospective Phase II Randomized Trial of Involved Nodal Versus Elective Neck RadioTherapy

INVERT - Prospective Phase II Randomized Trial of Involved Nodal Versus Elective Neck RadioTherapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

To determine the risk of solitary elective volume recurrence following involved nodal radiotherapy (INRT) versus elective nodal irradiation (ENI)

Detailed description

Patients are assigned to either elective nodal irradiation (ENI), the current treatment paradigm, or involved nodal radiotherapy (INRT), the experimental treatment. INRT is more specifically targeting potentially cancerous nodes, identified using an AI program developed in-house. The hope is that this more specific targeting will decrease healthy tissue being irradiated, therefore decreasing potential side effects of the radiation treatment. Patients are blinded during study participation.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	ENI using IMRT with or without chemotherapy	This study is a phase II single-blinded randomized trial comparing standard ENI with involved nodal radiotherapy. INRT using intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin- paclitaxel)
RADIATION	INRT	INRT using intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin- paclitaxel)
RADIATION	ENI	ENI using IMRT with or without chemotherapy

Timeline

• Start date: 2024-11-14
• Primary completion: 2028-07-01
• Completion: 2028-07-01
• First posted: 2024-06-27
• Last updated: 2026-04-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study