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New hope for head and neck cancer: which drug works best with radiation?

NCT ID NCT07441681

Disease control Sponsor: NRG Oncology Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 18, 2026 · Updated 2 times

Summary

This study compares two treatments for people with advanced head and neck cancer who cannot use the standard drug cisplatin. About 454 participants will receive either cetuximab (a targeted antibody) or a chemotherapy combo (carboplatin + paclitaxel) alongside precise radiation therapy. The goal is to see which approach better delays cancer growth and improves survival.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 454 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Nov 2040

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients must have pathologically confirmed, previously untreated, unresected squamous cell carcinoma of the larynx, hypopharynx, oropharynx, or oral cavity * Local evaluation of p16 status is required for all oropharynx patients prior to registration * Local evaluation of p16 status is recommended for non-oropharynx patients prior to registration * Locoregionally advanced head and neck squamous cell carcinoma (HNSCC) defined as: * Non-oropharynx and p16-negative oropharynx cancer: American Joint Commission on Cancer (AJCC) 8th edition stage III-IVB * Laryngeal, Hypopharyngeal, Oral Cavity, and p16-Negative Oropharyngeal Primaries: * AJCC 8th Edition TNM: T3-4b N0 M0 AJCC 8th Edition Stage: III-IVB * AJCC 8th Edition TNM: T1-4b N1-3 M0 AJCC 8th Edition Stage: III-IVB * p16-positive oropharynx cancer: AJCC 8th edition stage III and selected stage I-II based on smoking status in pack-years * Eligible p16-Positive Oropharyngeal Primaries * AJCC 8th Edition TNM: T1-2 N1 M0 AJCC 8th Edition Stage: I Pack-Years: \> 10 * AJCC 8th Edition TNM: T1-2 N2 M0 AJCC 8th Edition Stage: II Pack-Years: any * AJCC 8th Edition TNM: T3 N0-1 M0 AJCC 8th Edition Stage: II Pack-Years: \> 10 * AJCC 8th Edition TNM: T3 N2 M0 AJCC 8th Edition Stage: II Pack-Years: any * AJCC 8th Edition TNM: T1-3 N3 M0 AJCC 8th Edition Stage: III Pack-Years: any * AJCC 8th Edition TNM: T4 N0-3 M0 AJCC 8th Edition Stage: III Pack-Years: any * Note: Number of pack-years = \[Frequency of smoking (number of cigarettes per day) × duration of cigarette smoking (years)\] / 20 * Note: Cigar and pipe tobacco consumption is not included in calculating the lifetime pack-years. Marijuana consumption is likewise not considered in this calculation. There is also no clear scientific evidence regarding the role of chewing tobacco-containing products in oropharyngeal cancer, although this is possibly more concerning given the proximity of the oral cavity and oropharynx. In any case, investigators should not count use of non-cigarette tobacco products in the pack-years calculation * The following are required prior to registration: * Imaging of the head and neck with a neck CT or MRI (with contrast, unless contraindicated) or PET/CT which includes diagnostic-quality CT of the neck (with contrast, unless contraindicated) * Chest imaging: Chest CT (with contrast, unless contraindicated) or PET/CT * Age ≥ 18 * Complete the online tool at www.nrgoncology.org prior to registration and record the (modified) Charleston Comorbidity Index (CCI), Head and Neck Cancer Intergroup (HNCIG) omega, and G-8 scores on the registration form in Oncology Patient Enrollment Network (OPEN) * Patients must have a contraindication to cisplatin as defined in the following bullet points: * Absolute or relative contraindication to cisplatin, defined as ONE OR MORE of the following prior to registration: * Creatinine clearance (CrCl) \< 60 mL/min by the Cockroft-Gault formula * Pre-existing peripheral (sensory or motor) neuropathy grade ≥ 2 (per Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v\] 5.0) * History of hearing loss, defined as either: * Existing need of a hearing aid OR * ≥ 25 decibel shift over 2 contiguous frequencies on a pretreatment hearing test as clinically indicated OR * age ≥ 70 with Head and Neck Cancer Intergroup (HNCIG) omega score \< 0.80 prior to registration OR * Age \< 70 with ALL of the following conditions prior to registration (see Appendix II for calculation instructions): * HNCIG omega score \< 0.80 * (Modified) Charlson Comorbidity Index (CCI) ≥ 1 * G-8 score ≤ 14 * Not pregnant and not nursing * Participants must be able to safely receive the radiation and drug regimens per current Food and Drug Administration (FDA)-approved package insert(s), treating investigator's discretion, and institutional guidelines * No prior systemic therapy for the study cancer; note that prior systemic therapy for a different cancer is allowable * No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields * No prior surgery for the study cancer

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Conditions

The condition(s) this trial relates to.

carcinoma head and neck squamous cell carcinoma hypopharyngeal carcinoma hypopharynx cancer laryngeal carcinoma laryngeal neoplasm larynx cancer lip and oral cavity carcinoma lip and oral cavity squamous cell carcinoma Mouth Neoplasms oropharyngeal carcinoma oropharynx cancer oropharynx squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Clinical stage I HPV-mediated (P16-positive) oropharyngeal carcinoma ajcc V8 Clinical stage II HPV-mediated (P16-positive) oropharyngeal carcinoma ajcc V8 Clinical stage III HPV-mediated (P16-positive) oropharyngeal carcinoma ajcc V8 Head and neck squamous cell carcinoma Stage III hypopharyngeal carcinoma ajcc V8 Stage III laryngeal cancer ajcc V8 Stage III lip and oral cavity cancer ajcc V8 Stage III oropharyngeal (P16-negative) carcinoma ajcc V8 Stage IVA hypopharyngeal carcinoma ajcc V8 Stage IVA laryngeal cancer ajcc V8 Stage IVA lip and oral cavity cancer ajcc V8 Stage IVA oropharyngeal (P16-negative) carcinoma ajcc V8 Stage IVB hypopharyngeal carcinoma ajcc V8 Stage IVB laryngeal cancer ajcc V8 Stage IVB lip and oral cavity cancer ajcc V8 Stage IVB oropharyngeal (P16-negative) carcinoma ajcc V8

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    63 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aspirus Cancer Care - Stevens Point

    RECRUITING

    Stevens Point, Wisconsin, 54481, United States

  • Aspirus Cancer Care - Wisconsin Rapids

    RECRUITING

    Wisconsin Rapids, Wisconsin, 54494, United States

  • Aspirus Cancer Care-Antigo-Volm Cancer Center

    RECRUITING

    Antigo, Wisconsin, 54409, United States

  • Aspirus Cancer Care-Rhinelander-James Beck Cancer Center

    RECRUITING

    Rhinelander, Wisconsin, 54501, United States

  • Aspirus Cancer Care-Wausau

    RECRUITING

    Wausau, Wisconsin, 54401, United States

  • Bay Pines VA Healthcare System

    RECRUITING

    Bay Pines, Florida, 33744, United States

    Contact Email: •••••@•••••

  • Cancer Care Center of O'Fallon

    RECRUITING

    O'Fallon, Illinois, 62269, United States

  • Cancer Care Specialists of Illinois - Decatur

    RECRUITING

    Decatur, Illinois, 62526, United States

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

    Contact Email: •••••@•••••

  • Christiana Care Health System-Christiana Hospital

    RECRUITING

    Newark, Delaware, 19718, United States

  • Christiana Care Health System-Concord Health Center

    RECRUITING

    Chadds Ford, Pennsylvania, 19317, United States

  • Christiana Care Health System-Wilmington Hospital

    RECRUITING

    Wilmington, Delaware, 19801, United States

  • Decatur Memorial Hospital

    RECRUITING

    Decatur, Illinois, 62526, United States

  • Drexel Town Square Health Center

    RECRUITING

    Oak Creek, Wisconsin, 53154, United States

  • Froedtert Menomonee Falls Hospital

    RECRUITING

    Menomonee Falls, Wisconsin, 53051, United States

  • Froedtert West Bend Hospital/Kraemer Cancer Center

    RECRUITING

    West Bend, Wisconsin, 53095, United States

  • Froedtert and MCW Moorland Reserve Health Center

    RECRUITING

    New Berlin, Wisconsin, 53151, United States

  • HSHS Saint Elizabeth's Hospital

    RECRUITING

    O'Fallon, Illinois, 62269, United States

  • Helen F Graham Cancer Center

    RECRUITING

    Newark, Delaware, 19713, United States

  • Illinois CancerCare - Washington

    RECRUITING

    Washington, Illinois, 61571, United States

  • Illinois CancerCare-Bloomington

    RECRUITING

    Bloomington, Illinois, 61704, United States

  • Illinois CancerCare-Canton

    RECRUITING

    Canton, Illinois, 61520, United States

  • Illinois CancerCare-Carthage

    RECRUITING

    Carthage, Illinois, 62321, United States

  • Illinois CancerCare-Eureka

    RECRUITING

    Eureka, Illinois, 61530, United States

  • Illinois CancerCare-Galesburg

    RECRUITING

    Galesburg, Illinois, 61401, United States

  • Illinois CancerCare-Kewanee Clinic

    RECRUITING

    Kewanee, Illinois, 61443, United States

  • Illinois CancerCare-Macomb

    RECRUITING

    Macomb, Illinois, 61455, United States

  • Illinois CancerCare-Ottawa Clinic

    RECRUITING

    Ottawa, Illinois, 61350, United States

  • Illinois CancerCare-Pekin

    RECRUITING

    Pekin, Illinois, 61554, United States

  • Illinois CancerCare-Peoria

    RECRUITING

    Peoria, Illinois, 61615, United States

  • Illinois CancerCare-Peru

    RECRUITING

    Peru, Illinois, 61354, United States

  • Illinois CancerCare-Princeton

    RECRUITING

    Princeton, Illinois, 61356, United States

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Medical Oncology Hematology Consultants PA

    RECRUITING

    Newark, Delaware, 19713, United States

  • Mercy Hospital

    RECRUITING

    Cedar Rapids, Iowa, 52403, United States

  • Northwestern Medicine Glenview Outpatient Center

    RECRUITING

    Glenview, Illinois, 60026, United States

  • Northwestern Medicine Grayslake Outpatient Center

    RECRUITING

    Grayslake, Illinois, 60030, United States

  • Northwestern Medicine Lake Forest Hospital

    RECRUITING

    Lake Forest, Illinois, 60045, United States

    Contact Email: •••••@•••••

  • Northwestern Medicine Orland Park

    RECRUITING

    Orland Park, Illinois, 60462, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

    Contact Email: •••••@•••••

  • OSF Saint Francis Medical Center

    RECRUITING

    Peoria, Illinois, 61637, United States

  • OSF Saint Francis Radiation Oncology at Peoria Cancer Center

    RECRUITING

    Peoria, Illinois, 61615, United States

  • OSF Saint Joseph Medical Center

    RECRUITING

    Bloomington, Illinois, 61701, United States

  • Oncology Associates at Mercy Medical Center

    RECRUITING

    Cedar Rapids, Iowa, 52403, United States

  • ProMedica Flower Hospital

    RECRUITING

    Sylvania, Ohio, 43560, United States

    Contact Email: •••••@•••••

  • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

    RECRUITING

    Toledo, Ohio, 43606, United States

    Contact Email: •••••@•••••

  • Saint Francis Medical Center

    RECRUITING

    Cape Girardeau, Missouri, 63703, United States

  • Stony Brook University Medical Center

    RECRUITING

    Stony Brook, New York, 11794, United States

  • The James Graham Brown Cancer Center at University of Louisville

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • Tower Cancer Research Foundation

    RECRUITING

    Beverly Hills, California, 90211, United States

    Contact Email: •••••@•••••

  • USC / Norris Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90033, United States

  • University of Cincinnati Cancer Center-UC Medical Center

    RECRUITING

    Cincinnati, Ohio, 45219, United States

    Contact Email: •••••@•••••

  • University of Cincinnati Cancer Center-West Chester

    RECRUITING

    West Chester, Ohio, 45069, United States

    Contact Email: •••••@•••••

  • University of Kansas Cancer Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Kansas Cancer Center - Briarcliff

    RECRUITING

    Kansas City, Missouri, 64116, United States

  • University of Kansas Cancer Center - Lee's Summit

    RECRUITING

    Lee's Summit, Missouri, 64064, United States

  • University of Kansas Cancer Center - North

    RECRUITING

    Kansas City, Missouri, 64154, United States

  • University of Kansas Cancer Center-Overland Park

    RECRUITING

    Overland Park, Kansas, 66210, United States

  • University of Kansas Health System Saint Francis Campus

    RECRUITING

    Topeka, Kansas, 66606, United States

  • University of Kansas Hospital-Indian Creek Campus

    RECRUITING

    Overland Park, Kansas, 66211, United States

  • University of Kansas Hospital-Westwood Cancer Center

    RECRUITING

    Westwood, Kansas, 66205, United States

  • University of Kentucky/Markey Cancer Center

    RECRUITING

    Lexington, Kentucky, 40536, United States

  • UofL Health Medical Center Northeast

    RECRUITING

    Louisville, Kentucky, 40245, United States

    Contact Email: •••••@•••••

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