[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stage-ii-lip-and-oral-cavity-cancer-ajcc-v8\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stage-ii-lip-and-oral-cavity-cancer-ajcc-v8":167},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,56,68,118,146],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100053977",false,"NCT07195734","Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer","A Phase II Randomized Trial of Neoadjuvant Chemotherapy or Chemo-Immunotherapy in Patients With Recurrent\u002FPersistent PD-L1 Enriched Squamous Cell Carcinoma of the Head and Neck Undergoing Salvage Surgery (NEOPOLIS)","Inclusion Criteria:\n\n* Pathologically (histologically or cytologically) proven diagnosis of locally recurrent or persistent squamous cell carcinoma of head and neck (SCCHN) arising within the oral cavity, oropharynx, larynx, or hypopharynx\n* PD-L1 combined positive score (CPS) ≥ 1 using a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory\n* Verify insurance (or other payment) coverage for neoadjuvant chemotherapy\n* Measurable disease as defined by RECIST 1.1\n* Patients must have locally recurrent or persistent SCCHN arising within the oral cavity, oropharynx, larynx, or hypopharynx (American Joint Committee on Cancer \\[AJCC\\] Cancer Staging Manual, 8th Edition) AND are deemed candidates for salvage surgery:\n\n  * P16 positive oropharynx patients with T2, T3, T4, N0, N1, N2 and all other patients with T2, T3, T4a, N0, N1, N2a, N2b, N2c, N3a are eligible.\n  * Patients must be deemed surgically resectable without gross residual disease.\n  * For patients with oral cavity SCCHN, only those with recurrent or persistent disease after prior surgery are eligible.\n  * Patients who are candidates for salvage laryngectomy to treat recurrent laryngeal cancer and who are having salvage surgery for curative intent are eligible.\n  * Patients with resectable lymph node-only recurrence are eligible.\n  * No major vascular involvement (\\> 180° involvement of the common carotid or internal carotid artery), jugular foramen involvement, or prevertebral, paraspinous muscle involvement precluding a curative resection\n* No evidence of distant metastatic disease\n* The following minimum diagnostic workup is required:\n\n  * General history and physical examination.\n  * Diagnostic-quality neck CT and PET\u002FCT of neck (PET with attenuation-correction CT of neck, chest, and abdomen)\n* Age ≥ 18\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Negative urine or serum pregnancy test (in persons of childbearing potential) within 30 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal\n* Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm\\^3\n* Platelets ≥ 100,000 cells\u002Fmm\\^3\n* Hemoglobin ≥ 8.0 g\u002FdL (Note: The use of transfusion or other intervention to achieve hemoglobin \\[Hgb\\] ≥ 8.0 g\u002FdL is acceptable)\n* Adequate renal function defined as creatinine clearance (CrCL) \\> 50 mL\u002Fmin by the Cockcroft-Gault formula\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (Not applicable to patients with known Gilbert's syndrome)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 x institutional ULN\n* Only patients who received prior radiation therapy in the definitive or post-operative setting (limited to one course) are eligible.\n\n  * Prior radiation therapy must have been completed at least 6 months prior to registration with the majority of the index persistent\u002Frecurrent cancer volume (\\> 50%) irradiated to ≥ 40 Gy at the time\n* Prior systemic therapy including immunotherapy with anti-PD1 or anti-PDL1 within the definitive setting (neo-adjuvant, or adjuvant) is permitted and must have been completed at least 4 months prior to registration\n* Prior systemic therapy including immunotherapy for treatment of recurrent or metastatic SCCHN is not permitted\n* No investigational anti-cancer agents received within 4 weeks prior to registration\n* No New York Heart Association Functional Classification III or IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification)\n* No active infection requiring IV antibiotics, IV antiviral, or IV antifungal treatments\n* No peripheral neuropathy grade 3 or 4\n* No history of interstitial lung disease\n* No active, noninfectious pneumonitis requiring immunosuppressive therapy\n* No history of a solid organ transplant (other than corneal transplant)\n* No active autoimmune disease that has required systemic treatment in the past 2 years (i.e., use of disease-modifying agents, corticosteroids \\[\\> 10 mg prednisone\u002Fday or equivalent\\] or immunosuppressive drugs)\n\n  * NOTE: Patients meeting the following criteria are not considered immunosuppressed and are eligible to enroll:\n\n    * Patients who require a brief course of steroids (e.g., prophylaxis for imaging assessments due to hypersensitivity to contrast agents) are not excluded\n    * Patients with type I diabetes mellitus, and endocrinopathies (including hypothyroidism due to autoimmune thyroiditis) only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll\n    * Physiologic replacement doses ≤ 10 mg prednisone\u002Fday or equivalent are allowed. Inhaled or topical steroids are permitted\n* No history of allergic reaction to the study agent, compounds of similar chemical or biologic composition to the study agent, and immune checkpoint inhibitors (or any of its excipients)","ALL","18 Years",{"count":18,"type":19},180,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","This phase II trial tests the addition of chemotherapy, with carboplatin and paclitaxel, or chemo-immunotherapy, with carboplatin, paclitaxel and cemiplimab to standard salvage surgery followed by post operative radiation therapy and cisplatin for high risk patients, for the treatment of patients with PD-L1 positive head and neck squamous cell carcinoma that has come back and spread to nearby tissue or lymph nodes after a period of improvement (locally recurrent) or is persistent. 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. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Salvage surgery is surgery that takes place to remove tumor tissue after a failure of other treatment. High risk patients also receive radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Adding chemotherapy or chemo-immunotherapy to standard salvage surgery may kill more tumor cells than salvage surgery alone in patients with PD-L1 positive locally recurrent or persistent head and neck squamous cell carcinoma.",[25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42],"Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Locally Recurrent Head and Neck Squamous Cell Carcinoma","Locally Recurrent Hypopharyngeal Squamous Cell Carcinoma","Locally Recurrent Laryngeal Squamous Cell Carcinoma","Locally Recurrent Oral Cavity Squamous Cell Carcinoma","Locally Recurrent Oropharyngeal Squamous Cell Carcinoma","Stage II Laryngeal Cancer AJCC v8","Stage II Lip and Oral Cavity Cancer AJCC v8","Stage II Oropharyngeal (p16-Negative) 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 Laryngeal Cancer AJCC v8","Stage IVA Lip and Oral Cavity Cancer AJCC v8","Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage IVB Laryngeal Cancer AJCC v8","Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8","RECRUITING","2026-07-10",{"date":46,"type":47},"2026-07-13","ACTUAL",{"date":49,"type":47},"2026-04-24",{"date":51,"type":19},"2033-02-01",{"name":53,"class":54},"National Cancer Institute (NCI)","NIH",92,{"id":57,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":20,"phases":59,"briefSummary":23,"conditions":60,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":65,"leadSponsor":66,"locationsCount":67},"100607990",{"count":18,"type":19},[22],[25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42],"2026-07-01",{"date":63,"type":47},"2026-07-02",{"date":49,"type":47},{"date":51,"type":19},{"name":53,"class":54},87,{"id":69,"slug":4,"hasResults":10,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":20,"phases":76,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":117},"100556989","NCT06532279","Testing the Addition of the Drug BMX-001, a Radioprotector, or a Placebo to the Usual Chemoradiation Therapy for Patients With Head and Neck Cancer","A Randomized, Masked, Placebo Controlled, Phase II Trial Of Concurrent Chemoradiation With BMX-001 In Patients With Head And Neck Squamous Cell Carcinoma Receiving Concurrent Chemoradiation","Inclusion Criteria:\n\n* Patients must be planned to receive radiation and concurrent cisplatin chemotherapy as definitive therapy. Patients planned to receive concurrent cisplatin and radiation therapy in the adjuvant setting are not eligible.\n* At least two subsites (buccal mucosa, lips, retromolar trigone, floor of mouth, oral tongue, tonsil, soft palate, or hard palate) must have at least 1cc or 1% of the subsite volume receiving \\>= 50 Gy. In cases of uncertainty, the enrolling clinician can ensure coverage by inspecting the 50 Gy isodose line and using the table describing the anatomic boundaries of the individual subsites contained within the extended cavity contour. The two or more subsites receiving \\>= 50 Gy must be documented by the enrolling physician.\n* Pathologically confirmed (histologically or cytologically) squamous cell carcinoma of the oropharynx, larynx, hypopharynx, nasopharynx, or oral cavity.\n* P16 and\u002For human papillomavirus (HPV) status (via polymerase chain reaction \\[PCR\\] or in situ hybridization \\[ISH\\]) must be documented for patients with oropharynx cancer.\n* No patients with T0\u002FTx\u002Funknown primary disease.\n* No definitive clinical or radiologic evidence of metastatic (M1) disease related to current diagnosis.\n* Able to receive intensity-modulated radiation therapy (IMRT) delivered as daily fractions of 2.0 Gy once per weekday with a cumulative radiation dose of 70 Gy.\n* Age \\>= 18.\n* Zubrod performance status of 0-2.\n* Potassium ≥ institutional lower limit of normal (LLN) and magnesium ≥ institutional LLN. Oral or intravenous (IV) replacement therapy of potassium or magnesium is permitted if parameters can be met after repletion.\n* Absolute neutrophil count (ANC) \\>= 1,500 cells\u002Fmm\\^3.\n* Platelets \\>= 100,000 cells\u002Fmm\\^3.\n* Hemoglobin \\>= 9.0 g\u002Fdl (Note: The use of transfusion or other intervention to achieve hemoglobin \\[Hgb\\] \\>= 10.0 g\u002Fdl is acceptable).\n* Adequate renal function defined as creatinine clearance (CrCL) \\> 50 mL\u002Fmin by the Cockcroft-Gault formula.\n* Total bilirubin =\\\u003C 2 x institutional upper limit of normal (ULN) (not applicable to patients with known Gilbert's syndrome).\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 3 x institutional ULN.\n* No prior radiotherapy that would result in overlap of radiation treatment fields with planned treatment for study cancer, e.g., breast cancer with irradiation of the supraclavicular fossa\u002Flevel 4 neck.\n* No concurrent treatment with nitrates or other drugs that may, in the judgment of the treating investigator, create a risk for a precipitous decrease in blood pressure.\n* No prior history of gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease. In other words, to participate in this protocol, the patient must have clinically or radiographically evident gross disease for which disease response can be assessed.\n* No current treatment of adjuvant post-operative (op) chemoradiation.\n* No systemic treatment with inducers or strong inhibitors of cytochrome P450 =\\\u003C 4 days before registration. Note: Patients undergoing steroid treatment as a component of the anti-emetic regimen for cisplatin are eligible for the study. Treatment with the antifungal medications, nystatin, fluconazole , miconazole and clotrimazole are allowed.\n* No prior induction chemotherapy treatment.\n* No prior unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ, basal cell skin carcinoma, resected T1-2N0M0 differentiated thyroid cancers, Ta bladder cancers, or low risk prostate cancer.\n* No clinically significant hearing impairment that precludes cisplatin, as per physician assessment.\n* No serious cardiovascular disease or cerebrovascular disease in the last 6 months prior to study enrollment; defined as a cerebrovascular accident, myocardial infarction, unstable angina, serious cardiac arrhythmia uncontrolled by medication or with the potential to interfere with protocol treatment, or current New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF), or admission within last 6 months for CHF exacerbation; (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification).\n* No valvular heart disease.\n* No significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to enrollment.\n* No history or evidence upon physical\u002Fneurological examination of central nervous system disease (e.g., seizures) unrelated to cancer unless adequately controlled by medication.\n* No acute bacterial, viral, or fungal infection requiring intravenous antimicrobials within 7 days of enrollment.\n* No history of chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration.\n* No known personal or family history of long QT Syndrome; no marked baseline prolongation of QT\u002Fcorrected QT (QTc) interval (i.e., ≥ 2 electrocardiograms \\[EKGs\\] in prior 3 months of a QTc interval \\> 450 milliseconds (ms) for males and \\> 470 ms for females using the specific\u002Fusual choice by clinical center for correction factor.\n* Persistent grade 3-4 (CTCAE version 5.0) electrolyte abnormalities must be reversible to ≤ grade 1 with supplementation.\n* No poorly controlled hypertension (systolic blood pressure \\[SBP\\] \\> 160 and\u002For diastolic blood pressure \\[DBP\\] \\> 95) over 2 repeated measures within 30 days prior to registration.\n* No grade \\>= 2 oral mucositis per CTCAE version 5.0.\n* No grade \\>= 2 hypotension per CTCAE v. 5.0.\n* No medical necessity for anti-arrhythmics with significant risk of QTc prolongation such as class I and class III anti-arrhythmics. These include but are not limited to amiodarone, quinidine, dofetilide, sotalol, flecainide, and lidocaine.\n* No medical necessity for medications listed as prohibited.\n\n  * For standard management of oral mucositis, clinicians may consult the Multinational Association of Supportive Care in Cancer\u002FInternational Society of Oral Oncology (MASCC\u002FISOO) Clinical Practice Guidelines for the Management of Mucositis Secondary to Cancer Therapy. The only intervention against mucositis that is supported by level I evidence is low-level laser therapy (LLLT). Honey is rated at level II and benzydamine, which isn't available in the United States (US), is rated at level III. There are no other positively rated interventions.\n  * LLLT is prohibited in this study as its availability remains limited, it is not Food and Drug Administration (FDA) approved in the US, and it is considered investigational in many circumstances requiring enrollment in a dedicated protocol who requirements could conflict with this one. Therefore, institutions that use LLLT should only enroll patients who would not be eligible for (or do not want) that intervention. Honey is not on the list of prohibited medications for this study. Given the MASCC recommendation, benzydamine is allowed, although there is lack of availability in the United States of America (USA). The other listed prohibited medications are not recommended by MASCC and some are potentially harmful, such as glutamine, which is associated with mortality in patients receiving stem cell transplant.\n* No history of allergic reaction to the study agent(s), compounds of similar chemical or biologic composition to the study agent (s) (or any of its excipients).\n* Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal.",{"count":75,"type":19},98,[22],"This phase II trial compares the effectiveness of adding BMX-001 to usual symptom management versus usual symptom management alone for reducing oral mucositis in patients who are receiving chemoradiation for head and neck cancer. Oral mucositis (inflammation and mouth sores) is a common side effect of chemoradiation that can cause pain and difficulty swallowing. Usual management of these side effects typically consists of using mouth rinses and pain medications during treatment and for several weeks after completion of treatment. BMX-001 neutralizes harmful substances in the body, preventing damage to macromolecules such as DNA and minimizes free radical-related toxicity in normal tissues. Adding BMX-001 to usual symptom management may be more effective than usual symptom management alone at reducing oral mucositis in patients receiving chemoradiation for head and neck cancer.",[79,25,26,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,32,33,98,34,99,100,35,36,101,37,102,38,39,103,40,104,41,105,42,106],"Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Head and Neck Squamous Cell Carcinoma","Hypopharyngeal Squamous Cell Carcinoma","Laryngeal Squamous Cell Carcinoma","Nasopharyngeal Squamous Cell Carcinoma","Oral Cavity Squamous Cell Carcinoma","Oropharyngeal Squamous Cell Carcinoma","Stage 0 Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Stage 0 Hypopharyngeal Carcinoma AJCC v8","Stage 0 Nasopharyngeal Carcinoma AJCC v8","Stage 0 Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Stage I Hypopharyngeal Carcinoma AJCC v8","Stage I Laryngeal Cancer AJCC v8","Stage I Lip and Oral Cavity Cancer AJCC v8","Stage I Nasopharyngeal Carcinoma AJCC v8","Stage I Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage II Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Stage II Hypopharyngeal Carcinoma AJCC v8","Stage II Nasopharyngeal Carcinoma AJCC v8","Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Stage III Hypopharyngeal Carcinoma AJCC v8","Stage III Nasopharyngeal Carcinoma AJCC v8","Stage IVA Hypopharyngeal Carcinoma AJCC v8","Stage IVA Nasopharyngeal Carcinoma AJCC v8","Stage IVB Hypopharyngeal Carcinoma AJCC v8","Stage IVB Lip and Oral Cavity Cancer AJCC v8","Stomatitis","2026-06-22",{"date":109,"type":47},"2026-06-25",{"date":111,"type":47},"2025-06-23",{"date":113,"type":19},"2027-01-01",{"name":115,"class":116},"NRG Oncology","OTHER",153,{"id":119,"slug":4,"hasResults":10,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":20,"phases":126,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":139,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},"100388112","NCT04333537","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","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",{"count":125,"type":19},686,[22,127],"PHASE3","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.",[130,131,132,133,134,135,84,136,93,33,137,138],"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","Retromolar Trigone Squamous Cell Carcinoma","Tongue Squamous Cell Carcinoma","Upper Alveolar Ridge Squamous Cell Carcinoma",{"date":109,"type":47},{"date":141,"type":47},"2020-09-23",{"date":143,"type":19},"2031-04-27",{"name":115,"class":116},107,{"id":147,"slug":4,"hasResults":10,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":20,"phases":154,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":166},"100602291","NCT07121595","Personalized Neck Radiation Therapy Directed by Sentinel Lymph Node Biopsy for the Treatment of Oral Cavity Squamous Cell Carcinoma, PRECEDENT Trial","PRECEDENT: Pilot Phase II Study of Personalized Radiation to the Contralateral Neck Directed by Sentinel Node Evaluation in Lateralized Oral Cavity Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Patient must have biopsy-proven squamous cell carcinoma of the oral cavity\n* Clinical stage cT1-4a N0-2b M0 within 42 days of study enrollment based on the following work-up:\n\n  * History and physical examination within 42 days of study enrollment; must include documentation of lateralized primary tumor site\n  * Cross-sectional imaging of the head and neck within 42 days of study enrollment\n  * Cross-sectional imaging of the chest within 42 days of study enrollment\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 within 42 days of study enrollment\n* Age \\> 18\n* Recommended treatment plan is surgical resection with ipsilateral neck dissection and SPECT-CT-guided sentinel node biopsy. Flap reconstruction is allowed\n* Patient is willing and able to provide informed consent. Patient provides study-specific informed consent prior to study entry\n* Women of childbearing potential and male participants must agree to use medically effect means of birth control throughout their participation in the treatment phase of the study\n\nExclusion Criteria:\n\n* Evidence of distant metastatic disease based on clinical or radiologic evaluation\n* Evidence of contralateral neck disease on staging imaging\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 squamous cell carcinoma (SCC) in the oropharynx, nasopharynx, hypopharynx, and larynx\n* Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowed. Prior immunotherapy for the study cancer is allowed.\n* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields\n* Patient with severe, active co-morbidity that would preclude an elective or completion neck dissection\n* Pregnant and breast-feeding patients\n* Excisional biopsy for study cancer\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; incisional biopsy is permitted\n* Underlying or documented history of hematologic malignancy (e.g., chronic lymphocytic leukemia \\[CLL\\]) or other active disease capable of causing lymphadenopathy (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",{"count":153,"type":19},50,[22],"This phase II trial studies how well personalized neck radiation therapy directed by sentinel lymph node biopsy (SLNB) works in treating patients with oral cavity squamous cell carcinoma (OCSCC). SLNB can be performed as part of standard care for OCSCC. During SLNB, a radiotracer is injected around the tumor. The lymph nodes are then biopsied and tested to see if the tracer injected into the tumor traveled to and is present in the sentinel lymph nodes (SLNs). Results of the SLNB are used to determine whether lymph nodes should be removed in both sides of the neck or just on the same side as the primary tumor. Standard treatment then involves radiation therapy to both sides of the neck, regardless of SLNB results. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Studies have shown only a small number of patients develop a return of the cancer (recurrence) in the opposite side of the neck after radiation therapy. In addition, radiation therapy can negatively impact patient outcomes like saliva production, speech and swallow function, increased risk of radiation induced cancers, and chronic pain. Standard of care SLNBs may be effective in determining whether radiation therapy only needs to be administered to one side of the neck or both sides. This may help spare tissue on the opposite side of the neck from receiving radiation if there is no indication of lymph node involvement there.",[84,93,33,36,39],"2025-08-06",{"date":159,"type":47},"2025-08-13",{"date":161,"type":47},"2025-07-17",{"date":163,"type":19},"2030-07-01",{"name":165,"class":116},"University of Michigan Rogel Cancer Center",1,""]