[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100481064":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":35,"centralContacts":39,"locations":48,"responsibleParty":120,"collaborators":22,"id":122,"slug":123,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":22,"eligibilityCriteria":128,"healthyVolunteers":124,"sex":129,"minAge":130,"maxAge":22,"enrollmentInfo":131,"targetDuration":22,"studyType":134,"phases":135,"briefSummary":137,"conditions":138,"keywords":143,"overallStatus":51,"whyStopped":22,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},{"fullName":5,"class":6},"Memorial Sloan Kettering Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Participants with Squamous Cell Carcinoma Head and Neck Cancer","EXPERIMENTAL","Participants will be hypoxia-negative T0-3N1-2B small cell carcinoma head and neck cancer\u002FSCC HNC patients (HPV-OPC, HPV- UPC with nodal metastasis(es), HPC, or LXC) who are eligible for definitive CRT with de-escalated radiation concurrent with 2 cycles of SOC chemotherapy. Hypoxia status will be determined by the absence of hypoxia radiotracer uptake on 18F-FMISO PET\u002FCT imaging",[13,14,15],"Diagnostic Test: 18F-FMISO PET\u002FCT scan","Radiation: Chemoradiation therapy","Drug: Carboplatin",[17,23,30],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DIAGNOSTIC_TEST","18F-FMISO PET\u002FCT scan","18F-FMISO PET\u002FCT scan (only 1 injection) that occurs 5-10 treatment days after RT start",[9],null,{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"RADIATION","Chemoradiation therapy","* 18F-FMISO hypoxia negative patients complete CRT with 70Gy primary tumor and 50Gy de-escalated RT dose to gross nodes (if 50Gy is has pilot efficacy, then 44Gy to gross nodes; if 44Gy has pilot efficacy, then 40Gy to gross nodes).\n* 18F-FMISO hypoxia positive patients are taken off study and complete SOC 70Gy CRT to primary tumor and gross nodes.",[9],[29],"CRT",{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":22},"DRUG","Carboplatin","The chemotherapy used in this protocol is the standard of care for head and neck cancer, cisplatin or carboplatin\u002F5-Fluorouracil",[9],[36],{"name":37,"affiliation":5,"role":38},"Zeinab Abou Yehia, MD","PRINCIPAL_INVESTIGATOR",[40,44],{"name":37,"role":41,"phone":42,"phoneExt":22,"email":43},"CONTACT","212-639-3960","abouyez@mskcc.org",{"name":45,"role":41,"phone":46,"phoneExt":22,"email":47},"Eric Sherman, MD","646-608-3776","shermane@mskcc.org",[49,65,76,87,99,110],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)","RECRUITING","Basking Ridge","New Jersey","07920","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-74.54932,40.70621,{"lat":61,"lon":60},[64],{"name":37,"role":41,"phone":42,"phoneExt":22,"email":22},{"facility":66,"status":51,"city":67,"state":53,"zip":68,"country":55,"countryCode":56,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Memorial Sloan Kettering Monmouth (Limited Protocol Activities)","Middletown","07748",{"type":58,"coordinates":70},[71,72],-74.11709,40.39428,{"lat":72,"lon":71},[75],{"name":37,"role":41,"phone":42,"phoneExt":22,"email":22},{"facility":77,"status":51,"city":78,"state":53,"zip":79,"country":55,"countryCode":56,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Memorial Sloan Kettering Bergen (Limited Protocol Activities)","Montvale","07645",{"type":58,"coordinates":81},[82,83],-74.02292,41.04676,{"lat":83,"lon":82},[86],{"name":37,"role":41,"phone":42,"phoneExt":22,"email":22},{"facility":88,"status":51,"city":89,"state":90,"zip":91,"country":55,"countryCode":56,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)","Commack","New York","11725",{"type":58,"coordinates":93},[94,95],-73.29289,40.84288,{"lat":95,"lon":94},[98],{"name":37,"role":41,"phone":42,"phoneExt":22,"email":22},{"facility":100,"status":51,"city":101,"state":90,"zip":102,"country":55,"countryCode":56,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Memorial Sloan Kettering Westchester (Limited Protocol Activities)","Harrison","10604",{"type":58,"coordinates":104},[105,106],-73.71263,40.96899,{"lat":106,"lon":105},[109],{"name":37,"role":41,"phone":42,"phoneExt":22,"email":22},{"facility":111,"status":51,"city":90,"state":90,"zip":112,"country":55,"countryCode":56,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Memorial Sloan Kettering Cancer Center (All Protocol Activities)","10065",{"type":58,"coordinates":114},[115,116],-74.00597,40.71427,{"lat":116,"lon":115},[119],{"name":37,"role":41,"phone":42,"phoneExt":22,"email":22},{"type":121,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100481064","phase-2-a-study-of-decreasing-radiation-therapy-and-chemotherapy-in-people-with-head-and-neck-cancer-100481064",false,"NCT05544136","A Study of Decreasing Radiation Therapy and Chemotherapy in People With Head and Neck Cancer","A Pilot Study of Radiation De-Escalation for p16 Negative Oropharyngeal Cancer and p16-Negative or Positive Laryngeal and Hypopharyngeal Cancers","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of SCC of the head and neck (excluding nasopharynx, nasal cavity\u002Fparanasal sinus, oral cavity, salivary, thyroid, and cutaneous primary malignancies).\n\n  * Any unknown primary SCC of the head and neck with radiographically detectable gross nodes is allowed (core or excisional biopsy acceptable; if excisional biopsy is performed, there must be residual radiographically detectable nodal disease; FNA may be acceptable only with PI and\u002For co-PI approval)\n  * If the primary site is oropharynx or unknown primary, P16 IHC must be negative.\n  * If the primary site is hypopharynx or larynx, any P16 status is acceptable (positive, negative, or unknown). P16 IHC is strongly encouraged when possible.\n* Clinical stage T0-3 N1-2C M0 (AJCC 7th edition) without evidence of distant metastasis based on staging FDG PET\u002FCT.\n* 18 years of age or older.\n* Must not have received prior radiation therapy or chemotherapy for HNC.\n* Patients who have had their primary site tumor removed by surgery but still have residual grossly enlarged, radiographically detectable lymph nodes are eligible for this study.\n* Karnofsky Performance Status (KPS) ≥ 70.\n* CT or MRI of the Neck with and without contrast\n\n  o Note: A CT scan of the Neck and\u002For a PET\u002FCT performed for the purposes of radiation planning may serve as planning tools.\n* Adequate hematologic function within 30 days prior to registration, defined as follows:\n\n  * White Blood Count (WBC) ≥ 2,000 cells\u002FµL\n  * Absolute neutrophil count (ANC) ≥ 1,000 cells\u002Fmm3\n  * Platelets ≥ 100,000 cells\u002Fmm3\n  * Hemoglobin ≥ 8.0 g\u002FdL; Note: The use of transfusion or other interventions to achieve Hgb ≥ 8.0 g\u002FdL is acceptable\n* Adequate renal function within 30 days prior to registration, defined as follows:\n\n  * Serum creatinine \\\u003C 1.5 mg\u002FdL or creatinine clearance (CrCl) ≥ 50 mL\u002Fmin determined by 24-hour collection or estimated by Cockcroft-Gault formula: CrCl male = \\[(140 - age) x (weight in kg)\\] \u002F \\[(Serum Cr mg\u002FdL) x (72)\\] CrCl female = 0.85 x (CrCl male)\n  * Patients with serum creatinine \\> 1.5 mg\u002FdL can be eligible for carboplatin-based chemotherapy with approval of co-PI (Dr. Eric Sherman\n* Adequate hepatic function within 30 days prior to registration, defined as follows:\n\n  * Bilirubin \\\u003C 2 mg\u002FdL\n  * AST or ALT \\\u003C 3 x the upper limit of normal\n* Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential.\n* The subject\u002Flegally authorized representative (LAR) must provide study-specific informed consent prior to study entry.\n\nExclusion Criteria:\n\n* All nasopharyngeal, nasal cavity\u002Fparanasal sinus, oral cavity, salivary gland, thyroid, and cutaneous primary malignancies.\n* Any T4 or N3 patients\n* Any prior radiotherapy to the head and neck region.\n* Any prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different non-H\\&N cancer is permissible.\n* Prior chemotherapy or radiotherapy within the last three years.\n* Patients who underwent previous surgical resection for the same disease (except for biopsy or surgery removing primary site tumor but still present with grossly enlarged, radiographically detectable lymph nodes).\n* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 3 years or if cure rate from treatment at 5 years estimated to be ≥ 90%.\n* Subjects with simultaneous primary cancers outside of the oropharynx\n\n  o Note: Exceptions can be made for patients with simultaneous primaries outside the H\\&N if determined by the PI\u002FCo-PI that the patient can proceed with protocol activities.\n* Pregnant (confirmed by serum b-HCG in women of reproductive age) or breastfeeding.\n* Severe, active co-morbidities defined as follows:\n\n  * Unstable angina and\u002For congestive heart failure requiring hospitalization within the last 6 months.\n  * Transmural myocardial infarction within the last 6 months.\n  * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.\n  * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration.\n  * Hepatic Insufficiency resulting in clinical jaundice and\u002For coagulation defects.","ALL","18 Years",{"count":132,"type":133},12,"ESTIMATED","INTERVENTIONAL",[136],"PHASE2","The purpose of this study is to test the treatment approach of de-escalated radiation and chemotherapy followed by a planned neck dissection surgery in people with head and neck cancer. The study will look at how effective the treatment approach is against participants' cancer.",[139,140,141,142],"Head and Neck Cancer","Head and Neck Carcinoma","Head and Neck Neoplasms","Head and Neck Squamous Cell Carcinoma",[144,139,142,145,146,5,147],"Unknown Primary Squamous Cell Carcinoma","fluoromisonidazole","18F-FMISO","22-227","2026-02-25",{"date":150,"type":151},"2026-02-27","ACTUAL",{"date":153,"type":151},"2022-09-12",{"date":155,"type":133},"2027-03-12",{"name":5,"class":6},6]