RecruitingPhase 2NCT06477692

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


Sponsor

University of Texas Southwestern Medical Center

Enrollment

80 participants

Start Date

Nov 14, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study compares two radiation therapy approaches for head and neck cancers: standard elective neck radiation (treating a wider area including lymph nodes that appear cancer-free) versus involved nodal radiation (treating only lymph nodes that show signs of cancer). The goal is to see if a more targeted approach has fewer side effects with the same cancer control. **You may be eligible if...** - You have confirmed squamous cell carcinoma of the throat, voicebox (larynx), or upper throat (oropharynx or hypopharynx) - You have measurable disease that can be seen on imaging - You are in adequate overall health for radiation treatment **You may NOT be eligible if...** - Your cancer is from an unknown primary site - You have distant metastases (spread beyond the neck/head region) - You have had previous head and neck radiation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGENI 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)

RADIATIONINRT

INRT using intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin- paclitaxel)

RADIATIONENI

ENI using IMRT with or without chemotherapy


Locations(1)

UT Southwestern Medical Center

Dallas, Texas, United States

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NCT06477692


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