Head and Neck Cancer

Researchers are studying oral squamous cell carcinoma to evaluate the use of intraoral ultra-high frequency ultrasonography as a diagnostic tool. The goal is to improve visualization of oral soft tissue lesions beyond the mucosal surface, supporting clinical diagnosis with a minimally invasive, repeatable, and cost-effective imaging method. This study focuses on how this ultrasound technique may help assess tumor characteristics in the mouth. Participants diagnosed with oral squamous cell carcinoma and eligible for surgery will undergo an intraoral ultrasound scan using a 70 MHz frequency probe. This device is designed to measure tumor depth of invasion and thickness before surgery, providing detailed imaging of the oral soft tissues. The study involves only this experimental ultrasound procedure for patients meeting the criteria. During the study, participants will receive the ultrasound scan preoperatively to measure the depth of invasion of their tumor. Researchers will collect this measurement as the primary outcome to assess the ultrasound's diagnostic role. The study includes monitoring for safety and adherence, with participants followed until study completion. The total duration and follow-up specifics depend on each participant's surgical timeline and study protocols.

Researchers are evaluating an imaging test called zirconium Zr89 panitumumab combined with PET/CT scans to detect the spread of head and neck squamous cell carcinoma to other parts of the body. This phase I trial aims to assess how well 89Zr panitumumab identifies uncertain metastatic lesions compared to standard imaging methods like MRI, CT, and 18F-FDG PET/CT. The study focuses on the sensitivity and specificity of this investigational imaging agent in diagnosing metastatic disease. Participants will receive intravenous infusions of panitumumab and 89Zr panitumumab, followed by a PET/CT scan within 1 to 5 days after the infusion. They will also undergo standard care evaluations and treatments for their suspected metastatic lesions. The study compares 89Zr panitumumab PET/CT results to those from usual imaging techniques to determine its diagnostic value. During the study, participants will have blood tests to check hemoglobin, white blood cell count, platelet count, and kidney function. Researchers will monitor the imaging results to measure sensitivity and specificity over up to seven years. The study also tracks how often invasive procedures like biopsies are chosen versus observation. Participants will be followed and evaluated for safety and diagnostic accuracy throughout the study period.

Researchers are evaluating 177Lu-RAD204, a radiolabeled antibody targeting PD-L1, in a Phase 0/1 study involving participants with advanced solid tumors that express PD-L1. The study aims to assess the safety, tolerability, biodistribution, radiation dosimetry, and preliminary anti-tumor effects of this treatment. The main goal is to find the maximum tolerated dose and recommended doses for future studies in participants with cancers such as NSCLC, SCLC, triple-negative breast cancer, melanoma, head and neck cancer, endometrial cancer, and others with specific genetic markers. The study includes a pre-screening period for PD-L1 testing if needed, followed by a screening period lasting up to four weeks. Participants undergo a Phase 0 Imaging Period where a low dose of 177Lu-RAD204 is given to assess imaging quality, safety, and dosimetry over two weeks. This may be followed by a Phase 1 Treatment Period with escalating doses of 177Lu-RAD204 administered in cycles lasting six weeks each. Participants may receive multiple treatment cycles based on clinical benefit and safety evaluations. Dose-limiting toxicity is monitored for six weeks after the first treatment dose, and dosing intervals may be adjusted as agreed by the study team. During the study, participants will have imaging scans, safety evaluations, and laboratory tests to track the distribution and effects of 177Lu-RAD204. Researchers will measure pharmacokinetics, radiation dosimetry, and tumor responses up to 30 weeks. Safety and tolerability are closely monitored throughout. Participants must meet specific health and tumor criteria to join and will be observed for any adverse reactions. The total duration of participation varies depending on treatment response and tolerability.

Researchers are evaluating whether using 18F-FDG PET/CT scans to guide reduced-dose radiotherapy can maintain survival outcomes in patients with nasopharyngeal carcinoma (NPC). This phase II study focuses on patients with NPC stages I to IVA and investigates the effectiveness of adjusting radiation doses based on metabolic responses during treatment. Patients receive intensity modulated radiation therapy (IMRT) with two possible dosing plans depending on their metabolic response at the 25th radiation fraction. Those achieving complete metabolic response (CMR) or over 70% partial metabolic response (PMR) receive a reduced dose of 63.6 Gy delivered in 30 fractions, while others receive the conventional dose of 70 Gy in 33 fractions. Chemotherapy is also administered based on disease stage, with stage II patients receiving concurrent cisplatin during IMRT, and stage III-IVA patients receiving platinum-based induction chemotherapy followed by cisplatin concurrent with IMRT. Participants undergo regular imaging with 18F-FDG PET/CT to measure metabolic response, alongside clinical assessments of survival and complications. The primary outcome is local-regional recurrence-free survival at 5 years, with secondary outcomes including overall survival, progression-free survival, distant metastasis-free survival, treatment-related complications, and overall response rate measured over up to 5 years. The study duration and follow-up are designed to evaluate both short-term and long-term effects of the radiotherapy dosing strategies.

Researchers are evaluating the diagnostic value of a new protein-specific probe called 18F-T2 in PET/CT imaging for people with solid tumors that are likely to express high levels of CAIX protein. The study will also assess how safe and tolerable the 18F-T2 injection is, as well as measure its radiation dosage. This research is important to better understand how well 18F-T2 can detect these tumors compared to standard imaging techniques. Participants with tumors suspected to express high levels of CAIX will receive an intravenous injection of 18F-T2. About an hour after the injection, PET/CT imaging will be performed to capture detailed images of the tumors. Within one week, participants will also undergo a whole-body PET/CT scan using 18F-FDG, a commonly used imaging agent, to allow comparison between the two imaging methods. During the study, participants will be monitored for any adverse events within 24 hours after the 18F-T2 injection to evaluate safety and tolerability. Researchers will measure the diagnostic sensitivity and specificity of 18F-T2 PET/CT for detecting CAIX-positive tumors. They will also assess uptake values in tumors on both 18F-T2 and 18F-FDG scans, analyze the correlation between 18F-T2 uptake and CAIX expression in tissue samples, and evaluate radiation dosimetry. The study will continue until one month after completion for outcome assessments.

Researchers are evaluating whether giving 2 courses of cisplatin chemotherapy along with postoperative radiotherapy is as effective as 3 courses in treating patients with high-risk head and neck squamous cell carcinoma after surgery. This phase 3 randomized trial focuses on patients with advanced stages (III and IV) of this cancer type who have undergone radical surgery but have high-risk factors such as extracapsular invasion or positive surgical margins. The main goal is to compare the 3-year failure-free survival rates between the two treatment approaches. Participants will be assigned to one of two groups. One group receives intensity-modulated radiotherapy totaling more than 66 Gy, given once daily five days a week, combined with cisplatin chemotherapy at 100 mg/m2 through intravenous injection on days 1 and 22 (2 courses). The other group receives the same radiotherapy schedule plus 3 courses of cisplatin chemotherapy on days 1, 22, and 43. Both treatments are delivered under medical supervision to assess outcomes and side effects. During the study, participants will undergo regular assessments to evaluate failure-free survival, overall survival, distant metastasis-free survival, locoregional recurrence-free survival, and quality of life over a 3-year period. Safety and treatment tolerability will also be monitored. The trial includes close follow-up visits and evaluations to measure the effects of the different chemotherapy schedules combined with radiotherapy on cancer control and patient well-being.

Researchers are evaluating advanced radiation treatment methods called stereotactic body radiotherapy (SBRT) to see if they can safely deliver a stronger dose of radiation to tumors in patients with head and neck squamous cell carcinoma (HN SCC) who are not eligible for curative treatment. The study compares SBRT with traditional radiation methods to understand differences in local tumor control, symptom relief, side effects, and survival outcomes. Participants are randomly assigned to receive either traditional palliative radiation or SBRT, with radiation schedules determined by the study doctor. This Phase II trial aims to deliver radiation in fewer sessions with SBRT, potentially shortening treatment time compared to standard fractionated radiation. During the study, participants will undergo symptom assessments using the M. D. Anderson Symptom Inventory for head and neck cancer over about one year. Researchers will monitor pain response, symptom burden, tumor progression, and overall safety. The trial includes regular clinical evaluations and imaging to assess treatment effects, and participation may last up to approximately one year or more depending on individual follow-up.

Researchers are evaluating the safety and effectiveness of different courses of pembrolizumab combined with carboplatin and albumin-binding paclitaxel as preoperative (neoadjuvant) therapy in patients with resectable head and neck squamous cell carcinoma (stages T3 or T4, N0). This phase II, prospective, randomized study aims to compare four treatment cycles versus two cycles and assess outcomes such as pathological complete response, adverse events, survival rates, and radiological responses. The study also explores various factors that could influence treatment response and prognosis. Participants are randomly assigned to receive either four cycles or two cycles of pembrolizumab (200 mg IV), carboplatin (300 mg/m2 IV), and albumin-bound paclitaxel (260 mg/m2 IV) every 21 days, followed by surgery. Each treatment cycle occurs on day 1, and continuation depends on absence of disease progression or unacceptable toxicity. The study collects clinical, pathological, imaging, and serological data before and after treatment to evaluate the therapies. During the study, participants undergo assessments including imaging, pathology examination of tumor tissues, and laboratory tests. Researchers monitor adverse events for 90 days post-surgery and measure pathological response six weeks after treatment initiation. Longer-term outcomes such as event-free and overall survival are tracked for up to five years. Data on operation delays and radiographic responses are also gathered to assess treatment safety and efficacy throughout the study duration.

Researchers are studying patients with low-risk intermediate-stage nasopharyngeal carcinoma who have responded well to induction chemotherapy and have undetectable levels of plasma EBV-DNA. The trial compares two doses of radiotherapy targeting a specific low-risk area to evaluate their effects on survival, side effects, and quality of life. This phase 3 randomized study aims to find out if lower-dose radiotherapy can maintain treatment success while reducing toxicities related to treatment. Participants receive either reduced-dose radiotherapy (40.2Gy) or conventional-dose radiotherapy (49.2Gy) to the low-risk target volume called CTV2. Both groups undergo full-course immunotherapy with the PD-1 monoclonal antibody Tislelizumab, administered every three weeks, totaling 12 courses through induction, radiotherapy, and maintenance phases. Induction chemotherapy using a cisplatin-based regimen is given before radiotherapy. Treatment continues until toxicity, progression, withdrawal, or completion of planned courses. During the study, patients will be monitored for progression-free survival and serious adverse events over three years. Secondary measures include metastasis-free survival, relapse-free survival, overall survival, tumor response rates, and quality of life assessments using standard questionnaires over three years. Safety and effectiveness will be evaluated through imaging, laboratory tests, and clinical evaluations. The study enrollment includes adults aged 18 to 75 years, and the follow-up will provide information on long-term outcomes and treatment impact.

Researchers are evaluating the effects of 5-azacytidine and nivolumab, alone or combined, on HPV-associated head and neck squamous cell carcinoma that can be surgically removed. This Phase 2 trial aims to see if adding 5-azacytidine can make the cancer more responsive to treatment with nivolumab by boosting the immune system's attack on the tumor. The study focuses on patients with specific stages of oropharynx cancer confirmed to be HPV-related and involves measuring immune-related responses in the tumor tissue. Participants are randomly assigned to one of three groups: 5-azacytidine alone, nivolumab alone, or both drugs combined. 5-azacytidine is given intravenously once daily for five days starting on a Monday, with anti-nausea premedication. Nivolumab is administered intravenously twice, either on days 1 and 15 for the nivolumab group or days 2 and 16 for the combination group. Surgery is scheduled shortly after treatment, between days 16 and 18 for the monotherapy groups and days 17 to 18 for the combination group. During the study, patients undergo biopsies before and after treatment to assess tumor response and immune activity. Researchers measure immune-related pathologic response, tumor infiltration by immune cells, tumor size changes, and treatment toxicity. Safety is monitored from the first treatment through 30 days after surgery. Participants provide informed consent and must meet specific health criteria to join. The total involvement includes treatment, surgery, and follow-up assessments to evaluate the treatment effects.