NCT07441681RecruitingPhase 3
Comparing Radiation Plus Cetuximab to Radiation Plus Chemotherapy in People With Advanced Head and Neck Cancer Who Cannot Receive Cisplatin
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)
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 454 (estimated)
- First submitted
- 24 Feb 2026
- Start date
- 31 Jul 2026
- Primary completion date
- 30 Nov 2035
- Lead sponsor
- NRG Oncology
- Diseases
- Head and neck cancer
- NCT number
- NCT07441681
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 454
- From 31 Jul 2026 to the primary completion date, 30 Nov 2035
- 150 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (150)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of New Mexico Cancer Center Coordinator of this site? Confirm its status | Albuquerque | United States | Recruiting |
| Mary Greeley Medical Center Coordinator of this site? Confirm its status | Ames | United States | Recruiting |
| McFarland Clinic - Ames Coordinator of this site? Confirm its status | Ames | United States | Recruiting |
| Kaiser Permanente-Anaheim Coordinator of this site? Confirm its status | Anaheim | United States | Recruiting |
| Trinity Health Saint Joseph Mercy Hospital Ann Arbor Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
| Aspirus Cancer Care-Antigo-Volm Cancer Center Coordinator of this site? Confirm its status | Antigo | United States | Recruiting |
| Emory University Hospital Midtown Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Emory Proton Therapy Center Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Kaiser Permanente-Baldwin Park Coordinator of this site? Confirm its status | Baldwin Park | United States | Recruiting |
| Bay Pines VA Healthcare System Coordinator of this site? Confirm its status | Bay Pines | United States | Recruiting |
| Kaiser Permanente-Bellflower Coordinator of this site? Confirm its status | Bellflower | United States | Recruiting |
| Sanford Joe Lueken Cancer Center Coordinator of this site? Confirm its status | Bemidji | United States | Recruiting |
| Saint Charles Health System Coordinator of this site? Confirm its status | Bend | United States | Recruiting |
| Tower Cancer Research Foundation Coordinator of this site? Confirm its status | Beverly Hills | United States | Recruiting |
| University of Alabama at Birmingham Cancer Center Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| Sanford Bismarck Medical Center Coordinator of this site? Confirm its status | Bismarck | United States | Recruiting |
| OSF Saint Joseph Medical Center Coordinator of this site? Confirm its status | Bloomington | United States | Recruiting |
| Illinois CancerCare-Bloomington Coordinator of this site? Confirm its status | Bloomington | United States | Recruiting |
| Lafayette Family Cancer Center-EMMC Coordinator of this site? Confirm its status | Brewer | United States | Recruiting |
| Trinity Health IHA Medical Group Hematology Oncology - Brighton Coordinator of this site? Confirm its status | Brighton | United States | Recruiting |
| Sands Cancer Center Coordinator of this site? Confirm its status | Canandaigua | United States | Recruiting |
| Trinity Health IHA Medical Group Hematology Oncology - Canton Coordinator of this site? Confirm its status | Canton | United States | Recruiting |
| Trinity Health Medical Center - Canton Coordinator of this site? Confirm its status | Canton | United States | Recruiting |
| Illinois CancerCare-Canton Coordinator of this site? Confirm its status | Canton | United States | Recruiting |
| Saint Francis Medical Center Coordinator of this site? Confirm its status | Cape Girardeau | United States | Recruiting |
| Illinois CancerCare-Carthage Coordinator of this site? Confirm its status | Carthage | United States | Recruiting |
| Mercy Hospital Coordinator of this site? Confirm its status | Cedar Rapids | United States | Recruiting |
| Oncology Associates at Mercy Medical Center Coordinator of this site? Confirm its status | Cedar Rapids | United States | Recruiting |
| Christiana Care Health System-Concord Health Center Coordinator of this site? Confirm its status | Chadds Ford | United States | Recruiting |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Recruiting |
| Chelsea Hospital Coordinator of this site? Confirm its status | Chelsea | United States | Recruiting |
| Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Coordinator of this site? Confirm its status | Chelsea | United States | Recruiting |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| University of Cincinnati Cancer Center-UC Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| Clackamas Radiation Oncology Center Coordinator of this site? Confirm its status | Clackamas | United States | Recruiting |
| Mercy Cancer Center-West Lakes Coordinator of this site? Confirm its status | Clive | United States | Recruiting |
| Noyes Memorial Hospital/Myers Cancer Center Coordinator of this site? Confirm its status | Dansville | United States | Recruiting |
| Carle at The Riverfront Coordinator of this site? Confirm its status | Danville | United States | Recruiting |
| Geisinger Medical Center Coordinator of this site? Confirm its status | Danville | United States | Recruiting |
| Cancer Care Specialists of Illinois - Decatur Coordinator of this site? Confirm its status | Decatur | United States | Recruiting |
| Decatur Memorial Hospital Coordinator of this site? Confirm its status | Decatur | United States | Recruiting |
| Northwestern Medicine Cancer Center Kishwaukee Coordinator of this site? Confirm its status | DeKalb | United States | Recruiting |
| Mercy Medical Center - Des Moines Coordinator of this site? Confirm its status | Des Moines | United States | Recruiting |
| Geisinger Cancer Center Dickson City Coordinator of this site? Confirm its status | Dickson City | United States | Recruiting |
| Carle Physician Group-Effingham Coordinator of this site? Confirm its status | Effingham | United States | Recruiting |
| Illinois CancerCare-Eureka Coordinator of this site? Confirm its status | Eureka | United States | Recruiting |
| Sanford Roger Maris Cancer Center Coordinator of this site? Confirm its status | Fargo | United States | Recruiting |
| Sanford Broadway Medical Center Coordinator of this site? Confirm its status | Fargo | United States | Recruiting |
| Kaiser Permanente-Fontana Coordinator of this site? Confirm its status | Fontana | United States | Recruiting |
| Illinois CancerCare-Galesburg Coordinator of this site? Confirm its status | Galesburg | United States | Recruiting |
| Northwestern Medicine Cancer Center Delnor Coordinator of this site? Confirm its status | Geneva | United States | Recruiting |
| Northwestern Medicine Glenview Outpatient Center Coordinator of this site? Confirm its status | Glenview | United States | Recruiting |
| Northwestern Medicine Grayslake Outpatient Center Coordinator of this site? Confirm its status | Grayslake | United States | Recruiting |
| Kaiser Permanente South Bay Coordinator of this site? Confirm its status | Harbor City | United States | Recruiting |
| Penn State Milton S. Hershey Medical Center Coordinator of this site? Confirm its status | Hershey | United States | Recruiting |
| Methodist Willowbrook Hospital Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Kaiser Permanente-Irvine Coordinator of this site? Confirm its status | Irvine | United States | Recruiting |
| University of Wisconsin Carbone Cancer Center - Johnson Creek Coordinator of this site? Confirm its status | Johnson Creek | United States | Recruiting |
| University of Kansas Cancer Center Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| University of Kansas Cancer Center - North Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| University of Kansas Cancer Center - Briarcliff Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| Illinois CancerCare-Kewanee Clinic Coordinator of this site? Confirm its status | Kewanee | United States | Recruiting |
| Northwestern Medicine Lake Forest Hospital Coordinator of this site? Confirm its status | Lake Forest | United States | Recruiting |
| University of Michigan Health - Sparrow Lansing Coordinator of this site? Confirm its status | Lansing | United States | Recruiting |
| Lawrence Memorial Hospital Coordinator of this site? Confirm its status | Lawrence | United States | Recruiting |
| University of Kansas Cancer Center - Lee's Summit Coordinator of this site? Confirm its status | Lee's Summit | United States | Recruiting |
| Geisinger Medical Oncology-Lewisburg Coordinator of this site? Confirm its status | Lewisburg | United States | Recruiting |
| University of Kentucky/Markey Cancer Center Coordinator of this site? Confirm its status | Lexington | United States | Recruiting |
| Trinity Health Saint Mary Mercy Livonia Hospital Coordinator of this site? Confirm its status | Livonia | United States | Recruiting |
| Kaiser Permanente Los Angeles Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| USC / Norris Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Kaiser Permanente West Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| The Angeles Clinic and Research Institute - West Los Angeles Office Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| UofL Health Medical Center Northeast Coordinator of this site? Confirm its status | Louisville | United States | Recruiting |
| The James Graham Brown Cancer Center at University of Louisville Coordinator of this site? Confirm its status | Louisville | United States | Recruiting |
| Illinois CancerCare-Macomb Coordinator of this site? Confirm its status | Macomb | United States | Recruiting |
| University of Wisconsin Carbone Cancer Center - University Hospital Coordinator of this site? Confirm its status | Madison | United States | Recruiting |
| William S Middleton VA Medical Center Coordinator of this site? Confirm its status | Madison | United States | Recruiting |
| University of Wisconsin Carbone Cancer Center - Eastpark Medical Center Coordinator of this site? Confirm its status | Madison | United States | Recruiting |
| Carle Physician Group-Mattoon/Charleston Coordinator of this site? Confirm its status | Mattoon | United States | Recruiting |
| Froedtert Menomonee Falls Hospital Coordinator of this site? Confirm its status | Menomonee Falls | United States | Recruiting |
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Recruiting |
| Zablocki Veterans Administration Medical Center Coordinator of this site? Confirm its status | Milwaukee | United States | Recruiting |
| West Virginia University Healthcare Coordinator of this site? Confirm its status | Morgantown | United States | Recruiting |
| Vanderbilt University/Ingram Cancer Center Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Vanderbilt Breast Center at One Hundred Oaks Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Christiana Care Health System-Christiana Hospital Coordinator of this site? Confirm its status | Newark | United States | Recruiting |
| Medical Oncology Hematology Consultants PA Coordinator of this site? Confirm its status | Newark | United States | Recruiting |
| Helen F Graham Cancer Center Coordinator of this site? Confirm its status | Newark | United States | Recruiting |
| Providence Newberg Medical Center Coordinator of this site? Confirm its status | Newberg | United States | Recruiting |
| Froedtert and MCW Moorland Reserve Health Center Coordinator of this site? Confirm its status | New Berlin | United States | Recruiting |
| Northwestern Medicine Oak Brook Coordinator of this site? Confirm its status | Oak Brook | United States | Recruiting |
| Drexel Town Square Health Center Coordinator of this site? Confirm its status | Oak Creek | United States | Recruiting |
| Cancer Care Center of O'Fallon Coordinator of this site? Confirm its status | O'Fallon | United States | Recruiting |
| HSHS Saint Elizabeth's Hospital Coordinator of this site? Confirm its status | O'Fallon | United States | Recruiting |
| University of Oklahoma Health Sciences Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Recruiting |
| Kaiser Permanente-Ontario Coordinator of this site? Confirm its status | Ontario | United States | Recruiting |
| Providence Willamette Falls Medical Center Coordinator of this site? Confirm its status | Oregon City | United States | Recruiting |
| Northwestern Medicine Orland Park Coordinator of this site? Confirm its status | Orland Park | United States | Recruiting |
| Illinois CancerCare-Ottawa Clinic Coordinator of this site? Confirm its status | Ottawa | United States | Recruiting |
| University of Kansas Hospital-Indian Creek Campus Coordinator of this site? Confirm its status | Overland Park | United States | Recruiting |
| University of Kansas Cancer Center-Overland Park Coordinator of this site? Confirm its status | Overland Park | United States | Recruiting |
| Stanford Cancer Institute Palo Alto Coordinator of this site? Confirm its status | Palo Alto | United States | Recruiting |
| Kaiser Permanente - Panorama City Coordinator of this site? Confirm its status | Panorama City | United States | Recruiting |
| Illinois CancerCare-Pekin Coordinator of this site? Confirm its status | Pekin | United States | Recruiting |
| OSF Saint Francis Radiation Oncology at Peoria Cancer Center Coordinator of this site? Confirm its status | Peoria | United States | Recruiting |
| OSF Saint Francis Medical Center Coordinator of this site? Confirm its status | Peoria | United States | Recruiting |
| Illinois CancerCare-Peoria Coordinator of this site? Confirm its status | Peoria | United States | Recruiting |
| Illinois CancerCare-Peru Coordinator of this site? Confirm its status | Peru | United States | Recruiting |
| Fox Chase Cancer Center Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Temple University Hospital Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Providence Saint Vincent Medical Center Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Providence Portland Medical Center Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Illinois CancerCare-Princeton Coordinator of this site? Confirm its status | Princeton | United States | Recruiting |
| Aspirus Cancer Care-Rhinelander-James Beck Cancer Center Coordinator of this site? Confirm its status | Rhinelander | United States | Recruiting |
| VCU Massey Comprehensive Cancer Center Coordinator of this site? Confirm its status | Richmond | United States | Recruiting |
| VCU Massey Cancer Center at Stony Point Coordinator of this site? Confirm its status | Richmond | United States | Recruiting |
| Kaiser Permanente-Riverside Coordinator of this site? Confirm its status | Riverside | United States | Recruiting |
| University of Rochester Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| Wilmot Cancer Institute Radiation Oncology at Greece Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| Highland Hospital Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| UW Health Carbone Cancer Center Rockford Coordinator of this site? Confirm its status | Rockford | United States | Recruiting |
| Salina Regional Health Center Coordinator of this site? Confirm its status | Salina | United States | Recruiting |
| Kaiser Permanente-San Diego Zion Coordinator of this site? Confirm its status | San Diego | United States | Recruiting |
| Stanford Cancer Center South Bay Coordinator of this site? Confirm its status | San Jose | United States | Recruiting |
| Kaiser Permanente-San Marcos Coordinator of this site? Confirm its status | San Marcos | United States | Recruiting |
| Sanford Cancer Center Oncology Clinic Coordinator of this site? Confirm its status | Sioux Falls | United States | Recruiting |
| Sanford USD Medical Center - Sioux Falls Coordinator of this site? Confirm its status | Sioux Falls | United States | Recruiting |
| Aspirus Cancer Care - Stevens Point Coordinator of this site? Confirm its status | Stevens Point | United States | Recruiting |
| Stony Brook University Medical Center Coordinator of this site? Confirm its status | Stony Brook | United States | Recruiting |
| ProMedica Flower Hospital Coordinator of this site? Confirm its status | Sylvania | United States | Recruiting |
| Montefiore Medical Center - Moses Campus Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
| Montefiore Medical Center-Einstein Campus Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
| ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Coordinator of this site? Confirm its status | Toledo | United States | Recruiting |
| University of Kansas Health System Saint Francis Campus Coordinator of this site? Confirm its status | Topeka | United States | Recruiting |
| Carle Cancer Center Coordinator of this site? Confirm its status | Urbana | United States | Recruiting |
| Northwestern Medicine Cancer Center Warrenville Coordinator of this site? Confirm its status | Warrenville | United States | Recruiting |
| Illinois CancerCare - Washington Coordinator of this site? Confirm its status | Washington | United States | Recruiting |
| Aspirus Cancer Care-Wausau Coordinator of this site? Confirm its status | Wausau | United States | Recruiting |
| Wilmot Cancer Institute at Webster Coordinator of this site? Confirm its status | Webster | United States | Recruiting |
| Froedtert West Bend Hospital/Kraemer Cancer Center Coordinator of this site? Confirm its status | West Bend | United States | Recruiting |
| University of Cincinnati Cancer Center-West Chester Coordinator of this site? Confirm its status | West Chester | United States | Recruiting |
| Mercy Medical Center-West Lakes Coordinator of this site? Confirm its status | West Des Moines | United States | Recruiting |
| University of Kansas Hospital-Westwood Cancer Center Coordinator of this site? Confirm its status | Westwood | United States | Recruiting |
| Geisinger Wyoming Valley/Henry Cancer Center Coordinator of this site? Confirm its status | Wilkes-Barre | United States | Recruiting |
| Christiana Care Health System-Wilmington Hospital Coordinator of this site? Confirm its status | Wilmington | United States | Recruiting |
| Aspirus Cancer Care - Wisconsin Rapids Coordinator of this site? Confirm its status | Wisconsin Rapids | United States | Recruiting |
| Kaiser Permanente-Woodland Hills Coordinator of this site? Confirm its status | Woodland Hills | United States | Recruiting |
| Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Coordinator of this site? Confirm its status | Ypsilanti | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.