[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04333537":3,"trial-entities:NCT04333537":1355,"trial-summary:NCT04333537":1359},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":31,"study_type":32,"primary_purpose":33,"phases":34,"enrollment_info":37,"interventions":40,"primary_outcomes":132,"secondary_outcomes":144,"sex":187,"minimum_age":188,"maximum_age":189,"healthy_volunteers":15,"eligibility_criteria":190,"std_ages":228,"locations":231,"central_contacts":1349,"overall_officials":1350,"references":1353,"see_also_links":1354},"NCT04333537","NRG-HN006","Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection for Patients With Early-Stage Oral Cavity Cancer","Randomized Phase II\u002FIII Trial of Sentinel Lymph Node Biopsy Versus Elective Neck Dissection for Early-Stage Oral Cavity Cancer","RECRUITING","2036-04-27","2026-08","2026-08-17","2020-09-23","NRG Oncology","OTHER",false,"This phase II\u002FIII trial studies how well sentinel lymph node biopsy works and compares sentinel lymph node biopsy surgery to standard neck dissection as part of the treatment for early-stage oral cavity cancer. Sentinel lymph node biopsy surgery is a procedure that removes a smaller number of lymph nodes from your neck because it uses an imaging agent to see which lymph nodes are most likely to have cancer. Standard neck dissection, such as elective neck dissection, removes many of the lymph nodes in your neck. Using sentinel lymph node biopsy surgery may work better in treating patients with early-stage oral cavity cancer compared to standard elective neck dissection.","PRIMARY OBJECTIVES:\n\nI. To determine if patient-reported neck and shoulder function and related quality of life (QOL) at 6 months after surgery using the Neck Dissection Impairment Index (NDII) is superior with sentinel lymph node (SLN) biopsy compared to elective neck dissection (END) for treatment of early-stage oral cavity squamous cell carcinoma (OCSCC) (cT1-2N0). (Phase II) II. To determine if disease-free survival (DFS) is non-inferior with SLN biopsy compared to END for treatment of early-stage OCSCC (cT1-2N0). (Phase III) III. To determine if patient-reported neck and shoulder function and related QOL at 6 months after surgery using NDII is superior with SLN biopsy compared to END for treatment of early-stage OCSCC (cT1-2N0). (Phase III)\n\nSECONDARY OBJECTIVES:\n\nI. To compare patterns of failure (local-regional relapse and distant metastasis) between surgical arms.\n\nII. To measure and compare overall survival (OS) between surgical arms. III. To measure and compare the toxicity of the two surgical arms.\n\nIV. To measure longitudinal patient-reported neck and shoulder function and related QOL between surgical arms using the following instruments:\n\nIVa. Neck Dissection Impairment Index (NDII); IVb. Abbreviated Disabilities of the Arm, Shoulder and Hand (QuickDASH); IVc. Functional Assessment of Cancer Therapy-Head and Neck (FACT-H\\&N). V. To assess the length of hospitalization, post-operative drain placement, and operative morbidity between arms.\n\nVI. To estimate the negative predictive rate of fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)\u002Fcomputed tomography (CT) for N0 neck in patients with T1 and T1-2 oral cavity squamous cell cancer (OCSCC) patients in the END arm.\n\nVII. To assess nodal metastases rates between arms. VIII. To assess the pathologic false omission rate (FOR) in the SLN biopsy arm. IX. To determine if patient-reported neck and shoulder function using the NDII and related QOL at 6 months after surgery with SLN biopsy is superior to the END in low-risk patients.\n\nX. To compare the diagnostic performance of planar only versus (vs.) single photon emission computed tomography (SPECT)\u002FCT plus planar for SLN mapping (phase II only).\n\nEXPLORATORY OBJECTIVES:\n\nI. To compare changes in patient-reported outcomes (European Quality of Life Five Dimension Five Level Scale Questionnaire \\[EQ-5D-5L\\]) between surgical arms.\n\nII. To collect biospecimens for future translational science studies. III. To assess the DFS between arms in low-risk patients.\n\nOUTLINE: Patients are randomized to 1 of 2 groups.\n\nGROUP I: Patients receive an imaging agent via injection and undergo planar imaging and SPECT\u002FCT over 1-2 hours. Patients then undergo SLN biopsy. Patients also undergo FDG PET\u002FCT, CT, and\u002For chest x-ray at screening and during follow up.\n\nGROUP II: Patients undergo standard END. Patients also undergo FDG PET\u002FCT, CT, and\u002For chest x-ray at screening and during follow up.\n\nAfter completion of study treatment, patients are followed up 3 weeks after surgery, every 3 months for year 1, every 4 months for year 2, every 6 months for year 3, then yearly thereafter.",[19,20,21,22,23,24,25,26,27,28,29,30],"Buccal Mucosa Squamous Cell Carcinoma","Floor of Mouth Squamous Cell Carcinoma","Gingival Squamous Cell Carcinoma","Hard Palate Squamous Cell Carcinoma","Lip Squamous Cell Carcinoma","Lower Alveolar Ridge Squamous Cell Carcinoma","Oral Cavity Squamous Cell Carcinoma","Retromolar Trigone Squamous Cell Carcinoma","Stage I Lip and Oral Cavity Cancer AJCC v8","Stage II Lip and Oral Cavity Cancer AJCC v8","Tongue Squamous Cell Carcinoma","Upper Alveolar Ridge Squamous Cell Carcinoma",[],"INTERVENTIONAL","TREATMENT",[35,36],"PHASE2","PHASE3",{"count":38,"type":39},686,"ESTIMATED",[41,50,65,77,84,88,92,103,107,116],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":48},"PROCEDURE","Chest Radiography","Undergo chest x-ray",[46,47],"Group I (SLN biopsy)","Group II (END)",[49],"Chest X-ray",{"type":42,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"Computed Tomography","Undergo SPECT\u002FCT scan and FDG PET\u002FCT or CT",[46],[55,56,57,58,59,60,61,62,63,64],"CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized axial tomography (procedure)","Computerized Tomography","Computerized Tomography (CT) scan","CT","CT Scan","tomography",{"type":14,"name":66,"description":67,"armGroupLabels":68,"otherNames":69},"Fludeoxyglucose F-18","Undergo FDG PET\u002FCT",[46,47],[70,71,72,73,74,75,76],"18FDG","FDG","Fludeoxyglucose (18F)","fludeoxyglucose F 18","Fludeoxyglucose F18","Fluorine-18 2-Fluoro-2-deoxy-D-Glucose","Fluorodeoxyglucose F18",{"type":78,"name":79,"description":80,"armGroupLabels":81,"otherNames":82},"DRUG","Imaging Agent","Receive imaging agent via injection",[46],[83],"Image Enhancement Agent",{"type":42,"name":85,"description":86,"armGroupLabels":87},"Neck Dissection","Undergo standard elective neck dissection",[47],{"type":42,"name":89,"description":90,"armGroupLabels":91},"Planar Imaging","Undergo planar imaging",[46],{"type":42,"name":93,"description":67,"armGroupLabels":94,"otherNames":95},"Positron Emission Tomography",[46,47],[96,97,98,99,100,101,102],"Medical Imaging, Positron Emission Tomography","PET","PET Scan","Positron emission tomography (procedure)","Positron Emission Tomography Scan","Positron-Emission Tomography","PT",{"type":14,"name":104,"description":105,"armGroupLabels":106},"Questionnaire Administration","Ancillary studies",[46,47],{"type":42,"name":108,"description":109,"armGroupLabels":110,"otherNames":111},"Sentinel Lymph Node Biopsy","Undergo SLN biopsy",[46],[112,113,114,115],"Sentinel Node Biopsy","Sentinel node biopsy alone","SLNB","SNB",{"type":42,"name":117,"description":118,"armGroupLabels":119,"otherNames":120},"Single Photon Emission Computed Tomography","Undergo SPECT\u002FCT scan",[46],[121,122,123,124,125,126,127,128,129,130,131],"Medical Imaging, Single Photon Emission Computed Tomography","Single Photon Emission Tomography","Single-Photon Emission Computed","single-photon emission computed tomography","SPECT","SPECT imaging","SPECT SCAN","SPET","ST","tomography, emission computed, single photon","Tomography, Emission-Computed, Single-Photon",[133,137,140],{"measure":134,"description":135,"timeFrame":136},"Patient-reported neck and shoulder function (Phase II\u002FIII)","Will be evaluated and compared using the Neck Dissection Impairment Index (NDII), a 10-item tool between the two treatment arms. It is assumed that a 7.5-point between arm difference in the 6-month post-surgery NDII scores is clinically meaningful.","Before surgery (Baseline), 3 weeks after surgery, 3, 6, 12 months after surgery",{"measure":138,"description":139,"timeFrame":136},"Patient reported quality of life (QOL) (Phase II)","Will be measured using 3 questionnaires over 12-15 minutes.",{"measure":141,"description":142,"timeFrame":143},"Disease-free survival (DFS) (phase III)","Measured using Cox proportional hazards model and the Kaplan-Meier method. Failure includes local\u002Fregional recurrence, distant metastasis, or death due to any cause.","From randomization to local\u002Fregional recurrence, distant metastasis, or death due to any cause, whichever comes first, assessed up to 11 years",[145,149,153,157,161,165,168,172,175,179,183],{"measure":146,"description":147,"timeFrame":148},"Overall survival rate","Will be estimated using the Kaplan-Meier method and between-arm differences compared using the log-rank test.","From randomization to death due to any cause, assessed up to 11 years",{"measure":150,"description":151,"timeFrame":152},"Loco-regional failure","The cumulative incidence estimator will be used to estimate time to event distributions with between arm differences using cause-specific log-rank test.","From the time of randomization to the date of failure, date of precluding event, or last known follow-up date, assessed up to 11 years",{"measure":154,"description":155,"timeFrame":156},"Distant metastasis","The cumulative incidence estimator will be used to estimate event distributions with between arm differences tested using cause-specific log-rank test.","From the time of randomization to the date of distant metastasis, date of precluding event, or last known follow-up date, assessed up to 11 years",{"measure":158,"description":159,"timeFrame":160},"Toxicity","Measured by the Common Terminology Criteria for Adverse Events version 5.0. The proportion of patients with at least 1 grade 3 or higher adverse event will be compared between treatment arms.","Time of primary endpoint analysis",{"measure":162,"description":163,"timeFrame":164},"Patient-reported shoulder-related QOL, function impairment and disability","Patient reported using Abbreviated Disabilities of the Arm, Shoulder, and Hand (QuickDASH) with scores of 0-100. A higher score indicates greater disability.","Baseline, 3 weeks, 3, 6, 12 months post-surgery",{"measure":166,"description":167,"timeFrame":164},"General quality of life","Will be measured using the Functional Assessment of Cancer Therapy-Head and Neck to measure Functional Assessment of Cancer Therapy-Head and Neck-Trial Outcome Index scores on a scale from 0-96. A higher score indicates better quality of life.",{"measure":169,"description":170,"timeFrame":171},"Nodal metastasis detection rate","Defined as the proportion of patients with pathologic positive nodes using the pathology results.","At time of surgery",{"measure":173,"description":174,"timeFrame":171},"Pathologic false omission rate","Measured within the sentinel lymph node biopsy (SLN) arm only. Defined as the proportion of patients with false negative results among negative SLN patients.",{"measure":176,"description":177,"timeFrame":178},"Length of hospital stay","Length of hospital stay due to surgical procedure will be compared between arms using the Mann-Whitney test.","Prior to surgery, at time of discharge from surgery",{"measure":180,"description":181,"timeFrame":182},"Post-surgery patient-reported outcome","Measured by NDII in low-risk oral cavity squamous cell carcinoma patients using analysis of covariance comparison model.","At 6 months post-surgery",{"measure":184,"description":185,"timeFrame":186},"Diagnostic performance (Phase II only)","Descriptive statistics (minimum, maximum, mean, standard deviation, and coefficient of variation) of the number of detected SLNs will be calculated by modality and neck sublevel. The difference of the number of SLNs between single photon emission computed tomography\u002Fcomputed tomography plus planar and planar only will be computed and summarized by neck sublevel, reader, and overall. Pairwise absolute differences of the number of detected SLNs among readers will be computed and summarized by modality and neck sublevel.","Up to 11 years","ALL","18 Years",null,{"inclusion":191,"exclusion":212,"raw_text":227},[192,193,194,195,196,197,198,199,200,201,202,203,204,205,206,207,208,209,210,211],"PRIOR TO STEP 1 REGISTRATION INCLUSION:","Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (SCC) of the oral cavity, including the oral (mobile) tongue, floor of mouth (FOM), mucosal lip, buccal mucosa, lower alveolar ridge, upper alveolar ridge, retromolar gingiva (retromolar trigone; RMT), or hard palate prior to registration","Appropriate stage for study entry (T1-2N0M0; American Joint Committee on Cancer \\[AJCC\\] 8th edition \\[ed.\\]) based on the following diagnostic workup:","History\u002Fphysical examination within 42 days prior to registration","Imaging of head and neck within 42 days prior to registration","PET\u002FCT scan or contrast neck CT scan, or gadolinium-enhanced neck magnetic resonance imaging (MRI) or lateral and central neck ultrasound; diagnostic quality CT is preferred and highly recommended as part of the PET\u002FCT when possible","Imaging of chest within 42 days prior to registration","Chest x-ray, CT chest scan (with or without contrast), or PET\u002FCT (with or without contrast)","Surgical assessment within 42 days prior to registration. Patient must be a candidate for surgical intervention with sentinel lymph node (SLN) biopsy and potential completion neck dissection (CND) or elective neck dissection (END)","Surgical resection of the primary tumor will occur through a transoral approach with anticipation of resection free margins","Age \\>= 18","Zubrod performance status 0-2 within 42 days prior to registration","For women of child-bearing potential, negative serum or urine pregnancy test within 42 days prior to registration","The patient or a legally authorized representative must provide study-specific informed consent prior to study entry","Only patients who are able to read and understand English or French are eligible to participate as the mandatory patient reported NDII tool is only available in these languages","PRIOR TO STEP 2 RANDOMIZATION:","FDG PET\u002FCT required prior to step 2. Note: FDG PET\u002FCT done prior to step 1 can be submitted for central review","PET\u002FCT node negative patients, determined by central read, will proceed to randomization. PET\u002FCT node positive patients will go off study, but will be entered in a registry and data will be collected to record the pathological outcome of neck nodes for diagnostic imaging assessment and future clinical trial development","NOTE: All FDG PET\u002FCT scans must be performed on an American College of Radiology (ACR) accredited scanner (or similar accrediting organization)","The patient must complete NDII prior to step 2 registration",[213,214,215,216,217,218,219,220,221,222,223,224,225,226],"PRIOR TO STEP 1 REGISTRATION EXCLUSION:","Definitive clinical or radiologic evidence of regional (cervical) and\u002For distant metastatic disease","Prior non-head and neck invasive malignancy (except non-melanomatous skin cancer, including effectively treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or cervix) unless disease free for ≥ 2 years","Diagnosis of head and neck SCC in the oropharynx, nasopharynx, hypopharynx, and larynx","Unable or unwilling to complete NDII (baseline only)","Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for different cancer(s) is allowable","Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields","Severe, active co-morbidity that would preclude an elective or completion neck dissection","Pregnancy and breast-feeding mothers","Incomplete resection of oral cavity lesion with a positive margin; however, an excisional biopsy is permitted","Prior surgery involving the lateral neck, including neck dissection or gross injury to the neck that would preclude surgical dissection for this trial. Prior thyroid and central neck surgery is permissible; biopsy is permitted. Note: Borderline suspicious nodes that are \\>= 1 cm with radiographic finding suggestive of NOT malignant should be biopsied using ultrasound (U\u002FS)-guided fine-needle aspiration (FNA) biopsy","Underlying or documented history of hematologic malignancy (e.g., chronic lymphocytic leukemia \\[CLL\\]) or other active disease capable of causing lymphadenopathy (e.g., sarcoidosis or untreated mycobacterial infection)","Actively receiving systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte or immunomodulatory therapy","Currently participating in another investigational therapeutic trial","Inclusion Criteria:\n\n* PRIOR TO STEP 1 REGISTRATION INCLUSION:\n* Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (SCC) of the oral cavity, including the oral (mobile) tongue, floor of mouth (FOM), mucosal lip, buccal mucosa, lower alveolar ridge, upper alveolar ridge, retromolar gingiva (retromolar trigone; RMT), or hard palate prior to registration\n* Appropriate stage for study entry (T1-2N0M0; American Joint Committee on Cancer \\[AJCC\\] 8th edition \\[ed.\\]) based on the following diagnostic workup:\n\n  * History\u002Fphysical examination within 42 days prior to registration\n  * Imaging of head and neck within 42 days prior to registration\n\n    * PET\u002FCT scan or contrast neck CT scan, or gadolinium-enhanced neck magnetic resonance imaging (MRI) or lateral and central neck ultrasound; diagnostic quality CT is preferred and highly recommended as part of the PET\u002FCT when possible\n  * Imaging of chest within 42 days prior to registration\n\n    * Chest x-ray, CT chest scan (with or without contrast), or PET\u002FCT (with or without contrast)\n* Surgical assessment within 42 days prior to registration. Patient must be a candidate for surgical intervention with sentinel lymph node (SLN) biopsy and potential completion neck dissection (CND) or elective neck dissection (END)\n\n  * Surgical resection of the primary tumor will occur through a transoral approach with anticipation of resection free margins\n* Age \\>= 18\n* Zubrod performance status 0-2 within 42 days prior to registration\n* For women of child-bearing potential, negative serum or urine pregnancy test within 42 days prior to registration\n* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry\n* Only patients who are able to read and understand English or French are eligible to participate as the mandatory patient reported NDII tool is only available in these languages\n* PRIOR TO STEP 2 RANDOMIZATION:\n* FDG PET\u002FCT required prior to step 2. Note: FDG PET\u002FCT done prior to step 1 can be submitted for central review\n\n  * PET\u002FCT node negative patients, determined by central read, will proceed to randomization. PET\u002FCT node positive patients will go off study, but will be entered in a registry and data will be collected to record the pathological outcome of neck nodes for diagnostic imaging assessment and future clinical trial development\n\n    * NOTE: All FDG PET\u002FCT scans must be performed on an American College of Radiology (ACR) accredited scanner (or similar accrediting organization)\n* The patient must complete NDII prior to step 2 registration\n\nExclusion Criteria:\n\n* PRIOR TO STEP 1 REGISTRATION EXCLUSION:\n* Definitive clinical or radiologic evidence of regional (cervical) and\u002For distant metastatic disease\n* Prior non-head and neck invasive malignancy (except non-melanomatous skin cancer, including effectively treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or cervix) unless disease free for ≥ 2 years\n* Diagnosis of head and neck SCC in the oropharynx, nasopharynx, hypopharynx, and larynx\n* Unable or unwilling to complete NDII (baseline only)\n* Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for different cancer(s) is allowable\n* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields\n* Severe, active co-morbidity that would preclude an elective or completion neck dissection\n* Pregnancy and breast-feeding mothers\n* Incomplete resection of oral cavity lesion with a positive margin; however, an excisional biopsy is permitted\n* Prior surgery involving the lateral neck, including neck dissection or gross injury to the neck that would preclude surgical dissection for this trial. Prior thyroid and central neck surgery is permissible; biopsy is permitted. Note: Borderline suspicious nodes that are \\>= 1 cm with radiographic finding suggestive of NOT malignant should be biopsied using ultrasound (U\u002FS)-guided fine-needle aspiration (FNA) biopsy\n* Underlying or documented history of hematologic malignancy (e.g., chronic lymphocytic leukemia \\[CLL\\]) or other active disease capable of causing lymphadenopathy (e.g., sarcoidosis or untreated mycobacterial infection)\n* Actively receiving systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte or immunomodulatory therapy\n* Currently participating in another investigational therapeutic trial",[229,230],"ADULT","OLDER_ADULT",[232,242,258,270,282,288,301,310,323,336,343,354,367,377,391,401,414,424,434,447,455,469,479,487,491,504,512,524,538,548,561,568,576,584,598,611,621,632,642,652,663,676,688,695,698,712,725,738,748,758,769,783,793,803,810,823,830,840,844,850,854,864,878,886,889,903,916,930,944,951,961,968,982,995,1007,1017,1029,1042,1054,1067,1071,1082,1090,1097,1108,1122,1130,1140,1144,1157,1166,1178,1192,1205,1212,1218,1226,1236,1246,1259,1271,1279,1292,1303,1314,1324,1334],{"facility":233,"status":234,"city":235,"state":236,"zip":237,"country":238,"geoPoint":239},"University of Alabama at Birmingham Cancer Center","WITHDRAWN","Birmingham","Alabama","35233","United States",{"lat":240,"lon":241},33.52066,-86.80249,{"facility":243,"status":8,"city":244,"state":245,"zip":246,"country":238,"contacts":247,"geoPoint":255},"Banner MD Anderson Cancer Center","Gilbert","Arizona","85234",[248,252],{"name":249,"role":250,"phone":251},"Site Public Contact","CONTACT","602-747-9738",{"name":253,"role":254},"Thomas D. Shellenberger","PRINCIPAL_INVESTIGATOR",{"lat":256,"lon":257},33.35283,-111.78903,{"facility":259,"status":8,"city":260,"state":245,"zip":261,"country":238,"contacts":262,"geoPoint":267},"Mayo Clinic Hospital in Arizona","Phoenix","85054",[263,265],{"name":249,"role":250,"phone":264},"855-776-0015",{"name":266,"role":254},"Kyle S. Ettinger",{"lat":268,"lon":269},33.44838,-112.07404,{"facility":271,"status":8,"city":272,"state":245,"zip":273,"country":238,"contacts":274,"geoPoint":279},"Banner University Medical Center - Tucson","Tucson","85719",[275,277],{"name":249,"role":250,"email":276},"UACC-IIT@uacc.arizona.edu",{"name":278,"role":254},"Steven J. Wang",{"lat":280,"lon":281},32.22174,-110.92648,{"facility":283,"status":8,"city":272,"state":245,"zip":273,"country":238,"contacts":284,"geoPoint":287},"University of Arizona Cancer Center-North Campus",[285,286],{"name":249,"role":250,"email":276},{"name":278,"role":254},{"lat":280,"lon":281},{"facility":289,"status":8,"city":290,"state":291,"zip":292,"country":238,"contacts":293,"geoPoint":298},"University of Arkansas for Medical Sciences","Little Rock","Arkansas","72205",[294,296],{"name":249,"role":250,"phone":295},"501-686-8274",{"name":297,"role":254},"Emre A. 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Civantos",{"lat":412,"lon":413},25.72149,-80.26838,{"facility":415,"status":8,"city":416,"state":404,"zip":417,"country":238,"contacts":418,"geoPoint":421},"UM Sylvester Comprehensive Cancer Center at Deerfield Beach","Deerfield Beach","33442",[419,420],{"name":249,"role":250,"phone":408},{"name":410,"role":254},{"lat":422,"lon":423},26.31841,-80.09977,{"facility":425,"status":8,"city":426,"state":404,"zip":427,"country":238,"contacts":428,"geoPoint":431},"University of Miami Miller School of Medicine-Sylvester Cancer Center","Miami","33136",[429,430],{"name":249,"role":250,"phone":408},{"name":410,"role":254},{"lat":432,"lon":433},25.77427,-80.19366,{"facility":435,"status":8,"city":436,"state":437,"zip":438,"country":238,"contacts":439,"geoPoint":444},"Emory University Hospital Midtown","Atlanta","Georgia","30308",[440,442],{"name":249,"role":250,"phone":441},"888-946-7447",{"name":443,"role":254},"Jennifer Gross",{"lat":445,"lon":446},33.749,-84.38798,{"facility":448,"status":8,"city":436,"state":437,"zip":449,"country":238,"contacts":450,"geoPoint":454},"Emory University Hospital\u002FWinship Cancer Institute","30322",[451,453],{"name":249,"role":250,"phone":452},"404-778-1868",{"name":443,"role":254},{"lat":445,"lon":446},{"facility":456,"status":8,"city":457,"state":458,"zip":459,"country":238,"contacts":460,"geoPoint":466},"Northwestern University","Chicago","Illinois","60611",[461,464],{"name":249,"role":250,"phone":462,"email":463},"312-695-1301","cancer@northwestern.edu",{"name":465,"role":254},"Sandeep Samant",{"lat":467,"lon":468},41.85003,-87.65005,{"facility":470,"status":8,"city":457,"state":458,"zip":471,"country":238,"contacts":472,"geoPoint":478},"Rush MD Anderson Cancer Center","60612",[473,476],{"name":249,"role":250,"phone":474,"email":475},"312-226-2371","Cancer_Studies@rush.edu",{"name":477,"role":254},"Mihir K. 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study comparing two surgical methods for early-stage oral cavity cancer, aiming to enroll 686 participants.","completed","Comparing Sentinel Lymph Node Biopsy with Neck Dissection for Early Oral Cavity Cancer","This study is comparing two surgical approaches for early-stage oral cavity (mouth) cancer: sentinel lymph node (SLN) biopsy and standard neck dissection. SLN biopsy is a procedure where doctors use an imaging agent to find and remove only the lymph nodes most likely to contain cancer. Standard neck dissection removes many more lymph nodes. Researchers want to see if SLN biopsy leads to better neck and shoulder function and quality of life for patients, and if it is as effective in preventing cancer recurrence as standard neck dissection. You may be eligible if you are 18 or older and have a confirmed diagnosis of early-stage squamous cell carcinoma of the oral cavity. The study is currently recruiting 686 participants, but its overall status is unclear.","Your disease-free survival will be assessed for up to 11 years after randomization.",125,"You would undergo procedures like chest x-rays, CT scans, and potentially FDG PET\u002FCT scans. You would also receive an imaging agent injection and undergo either sentinel lymph node biopsy or neck dissection surgery. Your neck and shoulder function and quality of life would be measured at several points up to 12 months after surgery.","Not stated in the trial record.",[79,85],"v2"]