Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.
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Study Matches
Site for RANDOMIZED PHASE II/III TRIAL OF SENTINEL LYMPH NODE BIOPSY VERSUS ELECTIVE NECK DISSECTION FOR
EARLY-STAGE ORAL CAVITY CANCER (NRG-HN006) (PSCI# 20-085)
The purpose of this study is to see if neck and shoulder function and pain are better after SLN biopsy surgery compared to the usual approach and to see if SLN biopsy surgery is as good as the usual approach in extending your time without cancer. SLN biopsy surgery is potentially less invasive compared to the usual approach, but it requires a radioactive imaging agent to see the lymph nodes and it could also cause side effects. These side effects are described in the risks section below. Your study doctor will choose the appropriate imaging agent, Lymphoseek or sulfur colloid, for use in your surgery.
This study will help the study doctors find out if this different approach is better than the usual approach at improving neck and shoulder function. To decide if it is better, in the first part of the study, doctors will be looking to see if shoulder and neck function and quality of life are better after SLN biopsy surgery compared to the END surgery.
Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the oral cavity Age ≥ 18 Zubrod Performance Status 0-2 within 42 days prior to registration Only English speaking patients (able to read and understand English) are eligible to participate as the mandatory patient reported NDII tool is only available in this language For women of child bearing potential, negative serum or urine pregnancy test within 42 days prior to registration
Exclusion Criteria:
Definitive clinical or radiologic evidence of regional (cervical) and/or distant metastatic disease Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable Patient with severe, active co-morbidity that would preclude an elective or completion neck dissection Incomplete resection of oral cavity lesion with a positive margin; however, an excision biopsy is permitted Actively receiving systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte or immunomodulatory therapy.
KEYSTROKE: A RANDOMIZED PHASE II STUDY OF PEMBROLIZUMAB (KEYTRUDA®) PLUS STEREOTACTIC RE-IRRADIATION VERSUS SBRT ALONE FOR LOCOREGIONALLY RECURRENT OR SECOND PRIMARY HEAD AND NECK CARCINOMA
Study of Pembrolizumab (KEYTRUDA®) Plus non-surgical radiation therapy Versus non-surgical radiation therapy alone for Recurrent or Second Primary Head and Neck Cancer. This study is evaluating the safety of the addition of pembrolizumab to non-surgical radiation therapy.
Confirmed diagnosis of recurrent or any new primary squamous cell carcinoma of the head and neck Patients for whom resection would be medically contraindicated and/or would impose excessive surgical risk Patients must have had prior radiation to the head and neck
Exclusion Criteria:
Patients with distant metastases Tumors that involve more than 180 degrees of the carotid artery Patients with tumor ulceration through the skin Disease that requires two or more discontiguous target volumes will be ineligible.
Site for Randomized Phase II/III Trial of Adjuvant Radiation Therapy with Cisplatin, Docetaxel-Cetuximab, or Cisplatin-Atezolizumab in Pathologic High-Risk Squamous Cell Cancer of the Head and Neck (PSCI# 20-106) (RTOG-1216)
To determine if the combination of atezolizumab, cisplatin, and IMRT is superior to standard cisplatin and IMRT in the HNSCC.
Pathologically (histologically or cytologically) proven diagnosis of head and neck squamous cell carcinoma Patients must have undergone gross total surgical resection of high-risk oral cavity, oropharynx (p16 Negative), larynx, or hypopharynx within 63 days prior to registration Pathologic stage III or IV HNSCC, including no distant metastases Zubrod Performance Status of 0-1 within 14 days prior to registration Adequate hepatic function
Exclusion Criteria:
Prior systemic chemotherapy or anti-EGF therapy for the study cancer; note that prior chemo for a different cancer is allowable Severe, active co-morbidity Grade 3-4 electrolyte abnormalities Prior allergic reaction to cetuximab Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Site for Randomized Phase II/III Trial of Radiotherapy with Concurrent MEDI4736 (Durvalumab) vs. Radiotherapy with Concurrent Cetuximab in Patients with Locoregionally Advanced Head and Neck Cancer with a Contraindication to Cisplatin
The purpose of this study is to compare any good and bad effects of usual radiation plus the study treatment drug (durvalumab), to the usual therapy of radiation plus the drug (cetuximab) in patients with head and neck cancer who cannot take the drug cisplatin.
squamous cell carcinoma 18 or older Adequate hematologic function Adequate hepatic function Adequate renal function
Exclusion Criteria:
invasive malignancy within the past 3 years Prior radiotherapy Prior immunotherapy Major surgery within 28 days prior to Step 1 registration Uncontrolled hypertension
A Phase II, Randomized, Open-Label Three-Arm Clinical Study To Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination with Pembrolizumab (MK-3475) versus Standard of Care Chemotherapy and Lenvatinib Monotherapy in Participants with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) that have Progressed after Platinum Therapy and Immunotherapy (PD-1/PD-L1 inhibitors) (LEAP-009)
This study is designed to compare pembrolizumab plus lenvatinib as a combination therapy and standard of care (SOC) chemotherapy and see if its safe and effective for patients with recurrent or metastatic head and neck squamous cell carcinoma.
Be male or female and at least 18 years of age on the day of signing informed consent. Have histologically confirmed recurrent (not amenable to curative treatment with local and/or systemic therapies) or metastatic (disseminated) HNSCC Have experienced disease progression at any time during or after treatment with a platinum-containing (eg, carboplatin or cisplatin) regimen with or without cetuximab. Have submitted pre-study imaging that demonstrates evidence of disease progression based on investigator review of at least 2 pre-study images per RECIST 1.1, Have provided tissue for PD-L1 biomarker analysis from a core or excisional biopsy (fine needle aspirate is not adequate) not previously irradiated.
Exclusion Criteria:
Has carcinoma of the nasopharynx, salivary gland, unknown primary origin, or nonsquamous histologies as primary tumors. Has a history of re-irradiation to any head and neck sites of disease including the cervical, infraclavicular or supraclavicular lymph nodes for head and neck cancer. Has a life expectancy of less than 3 months and/or has rapidly progressing disease Has any evidence of symptoms or signs of active tumor bleeding within 6 months prior to randomization Has a history of (noninfectious) pneumonitis that required systemic steroids, or current pneumonitis/interstitial lung disease.
Site for A Phase II/III Randomized Study of Maintenance Nivolumab versus Observation in Patients with Locally Advanced, Intermediate Risk HPV Positive OPCA (PSCI# 20-016) (EA3161)
The purpose of this study is to compare the usual treatment alone (radiation and chemotherapy) to adding maintenance nivolumab to the usual treatment. The addition of nivolumab to the usual treatment could shrink your cancer or prevent it from returning. But, it could also cause side effects, which are described in the risks section below.
This study will help the study doctors find out if this different approach is better than the usual approach. To decide if it is better, the study doctors will be looking to see if the nivolumab increases the lifetime of the patient without progression for 10 years.
This immunotherapy drug, nivolumab, is already approved by the FDA for use in advanced and incurable head and neck cancer. But, most of the time it is not used until the cancer is very advanced and chemotherapy stops working. In this study we believe the use of nivolumab has a chance of preventing the cancer from coming back for patients with your type of cancer. There will be about 286 people taking part in the first part (phase II) of the study and 458 more people taking part in second part (phase III), if the results of the phase II portion are promising and if there is evidence that nivolumab may prolong your life.
Age ≥ 18 years. ECOG performance status of 0 or 1. Patients must have oropharynx cancer that is p16-positive by immunohistochemistry Adequate baseline organ and marrow function Adequate baseline liver functionality
Exclusion Criteria:
Patients with a history of allergic reactions attributed to platinum based chemotherapy agents Patients must not have had prior systemic therapy or radiation treatment for p16 positive OPSCC Patients must not have received previous irradiation for head and neck, tumor, skull base, or brain tumors Patients must not have known hypersensitivity to nivolumab Patients with evidence of distant metastases or leptomeningeal disease are excluded