[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626903":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":154,"centralContacts":153,"locations":153,"responsibleParty":158,"collaborators":153,"id":160,"slug":161,"hasResults":162,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":153,"eligibilityCriteria":166,"healthyVolunteers":162,"sex":167,"minAge":168,"maxAge":153,"enrollmentInfo":169,"targetDuration":153,"studyType":172,"phases":173,"briefSummary":175,"conditions":176,"keywords":153,"overallStatus":193,"whyStopped":153,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":153},{"fullName":5,"class":6},"NRG Oncology","OTHER",[8,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1 (IMRT, cetuximab)","EXPERIMENTAL","Patients undergo IMRT 5 days per week for 35 treatments. Starting within 7 days prior to radiation, patients receive a loading dose of cetuximab IV and then concurrently with radiation on day 1 of each cycle. Cycles repeat every 7 days for 7 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, PET scan on study and blood sample collection throughout the study. Patients may undergo PET scan or MRI during screening.",[13,14,15,16,17,18,19],"Procedure: Biospecimen Collection","Biological: Cetuximab","Procedure: Computed Tomography","Radiation: Intensity-Modulated Radiation Therapy","Procedure: Magnetic Resonance Imaging","Procedure: Positron Emission Tomography","Other: Survey Administration",{"label":21,"type":22,"description":23,"interventionNames":24},"Arm 2 (IMRT, carboplatin, paclitaxel)","ACTIVE_COMPARATOR","Patients undergo IMRT 5 days per week for 35 treatments. Starting on day 1 of radiation, patients receive concurrent carboplatin IV and paclitaxel on day 1 of each cycle. Cycles repeat every 7 days for 7 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, PET scan on study and blood sample collection throughout the study. Patients may undergo PET scan or MRI during screening.",[13,25,15,16,17,26,18,19],"Drug: Carboplatin","Drug: Paclitaxel",[28,37,63,79,96,107,127,137,149],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"PROCEDURE","Biospecimen Collection","Undergo blood sample collection",[9,21],[34,35,36],"Biological Sample Collection","Biospecimen Collected","Specimen Collection",{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"DRUG","Carboplatin","Given IV",[21],[43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62],"Blastocarb","Carboplat","Carboplatin Hexal","Carboplatino","Carboplatinum","Carbosin","Carbosol","Carbotec","CBDCA","Displata","Ercar","JM-8","JM8","Nealorin","Novoplatinum","Paraplatin","Paraplatin AQ","Paraplatine","Platinwas","Ribocarbo",{"type":64,"name":65,"description":40,"armGroupLabels":66,"otherNames":67},"BIOLOGICAL","Cetuximab",[9],[68,69,70,71,72,73,74,75,76,77,78],"C 225","C-225","C225","Cetuximab Biosimilar CDP-1","Cetuximab Biosimilar CMAB009","Cetuximab Biosimilar KL 140","Chimeric Anti-EGFR Monoclonal Antibody","Chimeric MoAb C225","Chimeric Monoclonal Antibody C225","Erbitux","IMC-C225",{"type":29,"name":80,"description":81,"armGroupLabels":82,"otherNames":83},"Computed Tomography","Undergo CT scan",[9,21],[84,85,86,87,88,89,90,91,92,93,94,95],"CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized axial tomography (procedure)","Computerized Tomography","Computerized Tomography (CT) scan","CT","CT Scan","Diagnostic CAT Scan","Diagnostic CAT Scan Service Type","tomography",{"type":97,"name":98,"description":99,"armGroupLabels":100,"otherNames":101},"RADIATION","Intensity-Modulated Radiation Therapy","Undergo IMRT",[9,21],[102,103,104,105,106],"IMRT","Intensity modulated radiation therapy (procedure)","Intensity Modulated RT","Intensity-Modulated Radiotherapy","Radiation, Intensity-Modulated Radiotherapy",{"type":29,"name":108,"description":109,"armGroupLabels":110,"otherNames":111},"Magnetic Resonance Imaging","Undergo MRI",[9,21],[112,113,114,115,116,117,118,119,120,121,122,123,124,125,126],"Magnetic Resonance","Magnetic Resonance Imaging (MRI)","Magnetic resonance imaging (procedure)","Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance \u002F Nuclear Magnetic Resonance","MR","MR Imaging","MRI","MRI Scan","MRIs","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging","sMRI","Structural MRI",{"type":38,"name":128,"description":40,"armGroupLabels":129,"otherNames":130},"Paclitaxel",[21],[131,132,133,134,135,136],"Anzatax","Asotax","Bristaxol","Praxel","Taxol","Taxol Konzentrat",{"type":29,"name":138,"description":139,"armGroupLabels":140,"otherNames":141},"Positron Emission Tomography","Undergo PET scan",[9,21],[142,143,144,145,146,147,148],"Medical Imaging, Positron Emission Tomography","PET","PET Scan","Positron emission tomography (procedure)","Positron Emission Tomography Scan","Positron-Emission Tomography","PT",{"type":6,"name":150,"description":151,"armGroupLabels":152,"otherNames":153},"Survey Administration","Ancillary studies",[9,21],null,[155],{"name":156,"affiliation":5,"role":157},"Loren K Mell","PRINCIPAL_INVESTIGATOR",{"type":159,"investigatorFullName":153,"investigatorTitle":153,"investigatorAffiliation":153,"oldNameTitle":153,"oldOrganization":153},"SPONSOR","100626903","phase-3-comparing-radiation-plus-cetuximab-to-radiation-plus-chemotherapy-in-people-with-head-and-neck-cancer-who-cannot-receive-cisplatin-100626903",false,"NCT07441681","Comparing Radiation Plus Cetuximab to Radiation Plus Chemotherapy in People With Head and Neck Cancer Who Cannot Receive Cisplatin","Radiotherapy With Concurrent Cetuximab vs. Carboplatin and Paclitaxel in Patients With Stage III-IVB Head and Neck Cancer With a Contraindication to Cisplatin: A Pragmatic Phase III Randomized Trial","Inclusion Criteria:\n\n* Patients must have pathologically confirmed, previously untreated, unresected squamous cell carcinoma of the larynx, hypopharynx, oropharynx, or oral cavity\n* Local evaluation of p16 status is required for all oropharynx patients prior to registration\n* Local evaluation of p16 status is recommended for non-oropharynx patients prior to registration\n* Locoregionally advanced head and neck squamous cell carcinoma (HNSCC) defined as:\n\n  * Non-oropharynx and p16-negative oropharynx cancer: American Joint Commission on Cancer (AJCC) 8th edition stage III-IVB\n\n    * Laryngeal, Hypopharyngeal, Oral Cavity, and p16-Negative Oropharyngeal Primaries:\n\n      * AJCC 8th Edition TNM: T3-4b N0 M0 AJCC 8th Edition Stage: III-IVB\n      * AJCC 8th Edition TNM: T1-4b N1-3 M0 AJCC 8th Edition Stage: III-IVB\n  * p16-positive oropharynx cancer: AJCC 8th edition stage III and selected stage I-II based on smoking status in pack-years\n\n    * Eligible p16-Positive Oropharyngeal Primaries\n\n      * AJCC 8th Edition TNM: T1-2 N1 M0 AJCC 8th Edition Stage: I Pack-Years: \\> 10\n      * AJCC 8th Edition TNM: T1-2 N2 M0 AJCC 8th Edition Stage: II Pack-Years: any\n      * AJCC 8th Edition TNM: T3 N0-1 M0 AJCC 8th Edition Stage: II Pack-Years: \\> 10\n      * AJCC 8th Edition TNM: T3 N2 M0 AJCC 8th Edition Stage: II Pack-Years: any\n      * AJCC 8th Edition TNM: T1-3 N3 M0 AJCC 8th Edition Stage: III Pack-Years: any\n      * AJCC 8th Edition TNM: T4 N0-3 M0 AJCC 8th Edition Stage: III Pack-Years: any\n\n        * Note: Number of pack-years = \\[Frequency of smoking (number of cigarettes per day) × duration of cigarette smoking (years)\\] \u002F 20\n        * 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\n* The following are required prior to registration:\n\n  * Imaging of the head and neck with a neck CT or MRI (with contrast, unless contraindicated) or PET\u002FCT which includes diagnostic-quality CT of the neck (with contrast, unless contraindicated)\n  * Chest imaging: Chest CT (with contrast, unless contraindicated) or PET\u002FCT\n* Age ≥ 18\n* 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)\n* Patients must have a contraindication to cisplatin as defined in the following bullet points:\n\n  * Absolute or relative contraindication to cisplatin, defined as ONE OR MORE of the following prior to registration:\n\n    * Creatinine clearance (CrCl) \\\u003C 60 mL\u002Fmin by the Cockroft-Gault formula\n    * Pre-existing peripheral (sensory or motor) neuropathy grade ≥ 2 (per Common Terminology Criteria for Adverse Events \\[CTCAE\\] version \\[v\\] 5.0)\n    * History of hearing loss, defined as either:\n\n      * Existing need of a hearing aid OR\n      * ≥ 25 decibel shift over 2 contiguous frequencies on a pretreatment hearing test as clinically indicated OR\n  * age ≥ 70 with Head and Neck Cancer Intergroup (HNCIG) omega score \\\u003C 0.80 prior to registration OR\n  * Age \\\u003C 70 with ALL of the following conditions prior to registration (see Appendix II for calculation instructions):\n\n    * HNCIG omega score \\\u003C 0.80\n    * (Modified) Charlson Comorbidity Index (CCI) ≥ 1\n    * G-8 score ≤ 14\n* Not pregnant and not nursing\n* 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\n* No prior systemic therapy for the study cancer; note that prior systemic therapy for a different cancer is allowable\n* No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields\n* No prior surgery for the study cancer","ALL","18 Years",{"count":170,"type":171},454,"ESTIMATED","INTERVENTIONAL",[174],"PHASE3","This phase III trial compares cetuxumab to chemotherapy, carboplatin and paclitaxel, with intensity modulated radiation therapy for the treatment of patients with head and neck cancer 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 cetxiumab or chemotherapy, with intensity modulated radiation therapy works best for the treatment of patients with head and neck cancer who are unable to receive cisplatin.",[177,178,179,180,181,182,183,184,185,186,187,188,189,190,191,192],"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","NOT_YET_RECRUITING","2026-04-28",{"date":196,"type":197},"2026-05-04","ACTUAL",{"date":199,"type":171},"2027-01-06",{"date":201,"type":171},"2035-11-30",{"name":5,"class":6}]