Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT07441681

PHASE3

Comparing Radiation Plus Cetuximab to Radiation Plus Chemotherapy in People With Advanced Head and Neck Cancer Who Cannot Receive Cisplatin

Sponsor: NRG Oncology

View on ClinicalTrials.gov

Summary

This phase III trial compares cetuximab to chemotherapy, carboplatin and paclitaxel, with intensity modulated radiation therapy for the treatment of patients with head and neck cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) who are unable to receive cisplatin. Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of cancer cells. This may help keep cancer cells from growing. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Intensity modulated radiation therapy is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. It is not yet know if cetuximab or chemotherapy, with intensity modulated radiation therapy works best for the treatment of patients with advanced head and neck cancer who are unable to receive cisplatin.

Official title: Radiotherapy With Concurrent Cetuximab vs. Carboplatin and Paclitaxel in Patients With Locoregionally Advanced Head and Neck Cancer With a Contraindication to Cisplatin: A Pragmatic Phase III Randomized Trial (CONCISE)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

454

Start Date

2026-07-31

Completion Date

2040-11-30

Last Updated

2026-10-27

Healthy Volunteers

Conditions

Locally Advanced Hypopharyngeal Squamous Cell Carcinoma Locally Advanced Laryngeal Squamous Cell Carcinoma Locally Advanced Oral Cavity Squamous Cell Carcinoma Locally Advanced Oropharyngeal Squamous Cell Carcinoma

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

DRUG

Carboplatin

Given IV

BIOLOGICAL

Cetuximab

Given IV

PROCEDURE

Computed Tomography

Undergo FDG PET/CT and CT or PET/CT

RADIATION

Intensity-Modulated Radiation Therapy

Undergo IMRT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Paclitaxel

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET/CT and/or FDG PET/CT

OTHER

Survey Administration

Ancillary studies

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) 9th edition stage III-IVB * Eligible Laryngeal, Hypopharyngeal, Oral Cavity, and p16-Negative Oropharyngeal Primaries: * AJCC 9th Edition TNM: T3 N0 or T1-3 N1 M0; AJCC 9th Edition Stage: III * AJCC 9th Edition TNM: T1-3 N2 or T4a N0-N2 M0; AJCC 9th Edition Stage: IVA * AJCC 9th Edition TNM: T4b N0-N2 or T1-4b N3 M0; AJCC 9th Edition Stage: IVB * p16-positive oropharynx cancer: AJCC 9th edition stage II-III * Eligible p16-Positive Oropharyngeal Primaries * AJCC 9th Edition TNM: T3 N0-2 or T1-2 N2 M0; AJCC 9th Edition Stage: II * AJCC 9th Edition TNM: T4 N0-3 or T1-3 N3 M0; AJCC 9th Edition Stage: III * 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

Locations (150)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Kaiser Permanente-Anaheim

Anaheim, California, United States

Kaiser Permanente-Baldwin Park

Baldwin Park, California, United States

Kaiser Permanente-Bellflower

Bellflower, California, United States

Tower Cancer Research Foundation

Beverly Hills, California, United States

Kaiser Permanente-Fontana

Fontana, California, United States

Kaiser Permanente South Bay

Harbor City, California, United States

Kaiser Permanente-Irvine

Irvine, California, United States

The Angeles Clinic and Research Institute - West Los Angeles Office