Recruiting

Involved Nodal vs Elective Neck Radiotherapy for Cancer

Study Aim

This study aims to evaluate whether involved nodal radiotherapy is as effective as elective neck radiotherapy in treating cancer patients, by comparing the probability of specific outcomes at two years.

What is being tested

ENI using IMRT with or without chemotherapy

+ INRT

+ ENI

DrugRadiation

Who is being recruted

Head and Neck Neoplasms

+ Neoplasms

+ Neoplasms by Site

From 18 to 99 Years

+23 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: November 2024

See protocol details

Summary

Principal SponsorUniversity of Texas Southwestern Medical Center

Study ContactSarah NeufeldMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: November 14, 2024

Actual date on which the first participant was enrolled.

This clinical trial is exploring a new way to use radiation therapy for patients with cancer in their neck. Specifically, the study focuses on comparing two methods of radiation treatment. The standard method, elective nodal irradiation (ENI), involves radiating a wider area, including both cancerous and healthy tissue. The experimental method, involved nodal radiotherapy (INRT), aims to target only the potentially cancerous areas, using advanced technology with an artificial intelligence program to identify these nodes more precisely. The goal is to reduce the amount of healthy tissue exposed to radiation, potentially leading to fewer side effects, which could improve the quality of life for patients undergoing treatment. Participants in this study are divided into two groups: one receiving the standard treatment and the other receiving the experimental treatment. The study is conducted in a way that keeps participants unaware of which treatment they are receiving, ensuring unbiased results. Researchers will closely monitor the effects of both treatments, particularly looking at how well cancer is controlled and the side effects experienced. By comparing these two approaches, the study seeks to determine if the new method is as effective as the standard treatment, while offering the potential benefit of fewer side effects.

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

NCT06477692

Principal SponsorUniversity of Texas Southwestern Medical Center

Study ContactSarah NeufeldMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 99 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Head and Neck NeoplasmsNeoplasmsNeoplasms by Site

Criteria

10 inclusion criteria required to participate

Pathologically-proven diagnosis of squamous cell carcinoma of the oropharynx, larynx, or hypopharynx. Squamous cell carcinoma of unknown primary is not allowed.

Patients must have clinically or radiographically evident measureable disease at the primary site and/or nodal stations. Diagnostic lymph node excision (≤ 2 nodes) is also allowable.

Patients may undergo a diagnostic or therapeutic transoral resection for a T1-2 tonsil or base of tongue cancer.

Clinical stage I-IVB (AJCC, 7th edition); stages I-II glottic cancer are excluded

Show More Criteria

13 exclusion criteria prevent from participating

Distant metastasis.

Inability to undergo either a diagnostic CT with contrast or simulation CT with contrast.

Inability to undergo PET-CT.

Stage I and II glottic carcinoma.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

After the involved and suspicious nodes are contoured, the physician will contour remaining nodes that are present on more than one CT slice and submit them to the AI-Radiomics module for assessment.The nodal gross tumor volume (GTVn, GTVns and GTVnps for involved, suspicious nodes or potentially suspicious) will be contoured on the planning CT, using radiographic and clinical information to define its extent. The total dose for GTVns is 63 Gy in 35 fractions, and the total dose for GTVnps is 56 Gy in 35 fractions. For lymph nodes identified as potentially suspicious by the AI- Radiomics module that are outside of the expected primary draining zone, physicians may not treat the lymph node if the module assesses its estimation uncertainty as greater than 50%.

Group II

Active Comparator

The elective neck dose is 56 Gy in 35 fractions Lymph nodes measuring 17 mm or greater in any dimension, or showing FDG above adjacent blood pool, may receive 63 Gy in 35 fractions per physician discretion.The elective neck field is determined by the primary site. The Oropharynx: Node-positive side: Levels IB-V and RP nodes Node-negative side: Levels II-IV, RP at discretion of physician For ipsilateral tonsil decision-making, see 4.1.1.6.3 The Larynx: Node-positive side: Levels IB-V Node-negative side: Levels II-IV Subglottic extension: Level VI Hypopharynx: Node-positive side: Levels IB-V and RP nodes Node-negative side: Levels II-V and RP nodes Pyriform sinus involvement: Level VI

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

UT Southwestern Medical Center

Dallas, United StatesOpen UT Southwestern Medical Center in Google Maps

Recruiting

One Study Center