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Head and Neck Neoplasms clinical trials

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NCT ID: NCT03085719 Active, not recruiting - Clinical trials for Head and Neck Cancer

Targeting PD-1 Therapy Resistance With Focused High or High and Low Dose Radiation in SCCHN

Start date: June 30, 2017
Phase: Phase 2
Study type: Interventional

This research study is studying immunotherapy in combination with radiation therapy as a possible treatment for head & neck cancer that has worsened or spread to another organ or part of your body. The immunotherapy involved in this study is: MK-3475 (pembrolizumab or KEYTRUDA).

NCT ID: NCT03082534 Active, not recruiting - Clinical trials for Head and Neck Cancer

Pembrolizumab Combined With Cetuximab for Treatment of Recurrent/Metastatic Head & Neck Squamous Cell Carcinoma

Start date: March 28, 2017
Phase: Phase 2
Study type: Interventional

This is a prospective, multi-center, open-label, non-randomized, multi-arm phase II trial to evaluate the efficacy of combination therapy with pembrolizumab and cetuximab for patients with recurrent/metastatic HNSCC. There will be four patient cohorts, including a PD-1/PD-L1 inhibitor-naïve, cetuximab-naïve arm (Cohort 1), a PD-1/PD-L1 inhibitor-refractory, cetuximab-naïve arm (Cohort 2), a PD-1/PD-L1 inhibitor-refractory, cetuximab-refractory arm (Cohort 3), and a cutaneous HNSCC arm (Cohort 4). A total of 83 patients (33 in Cohort 1, 25 in Cohort 2, 15 in Cohort 3, and 10 in Cohort 4) will be eligible to enroll. Patients will be enrolled at 4 sites: UC San Diego Moores Cancer Center, UC Los Angeles Jonsson Comprehensive Cancer Center, University of Michigan Comprehensive Cancer Center, and University of Washington Siteman Cancer Center.

NCT ID: NCT03076281 Active, not recruiting - Larynx Clinical Trials

Metformin Hydrochloride and Doxycycline in Treating Patients With Head and Neck Squamous Cell Carcinoma That Can Be Removed by Surgery

Start date: April 3, 2017
Phase: Phase 2
Study type: Interventional

This randomized phase II trial studies how well metformin hydrochloride and doxycycline work in treating patients with head and neck squamous cell carcinoma that can be removed by surgery. Metformin hydrochloride may reduce the metabolic activity of cancer cells and of surrounding supportive tissue. Doxycycline may minimize toxic side effects of anti-cancer therapy. Giving metformin hydrochloride and doxycycline may work better in treating patients with head and neck squamous cell carcinoma.

NCT ID: NCT03053661 Active, not recruiting - Clinical trials for Head and Neck Squamous Cell Carcinoma

Immune Response Evaluation to Curative Conventional Therapy

IRECT-01
Start date: August 2013
Phase:
Study type: Observational

The IRECT trial is a non-interventional, prospective clinical trial using modern immune monitoring techniques over the course of the standard of care for HNSCC. The dynamics of host/tumor immune interactions during the conventional standard treatment will be analyzed to find the most promising target antigen and to develop a strategy how and when specific immunotherapy should be added to the current treatment schedule. The results from this trial will help to understand how state of the art treatment can be complemented using cancer-testis antigen specific vaccines and immune-modulating drugs to improve the outcome of head and neck cancer patients.

NCT ID: NCT03040999 Active, not recruiting - Clinical trials for Head and Neck Neoplasms

Study of Pembrolizumab (MK-3475) or Placebo With Chemoradiation in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-412/KEYNOTE-412)

Start date: April 5, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the efficacy and safety of pembrolizumab given concomitantly with chemoradiation (CRT) and as maintenance therapy versus placebo plus CRT in participants with locally advanced head and neck squamous cell carcinoma (LA HNSCC). The primary hypothesis is that pembrolizumab in combination with CRT is superior to placebo in combination with CRT with respect to event-free survival (EFS).

NCT ID: NCT03019003 Active, not recruiting - Clinical trials for Head and Neck Cancer

Oral Decitabine (ASTX727) and Durvalumab in Recurrent and/or Metastatic Head and Neck Cancer Patients

Start date: March 20, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This is a non-randomized, open-label, Phase IbI study to assess the safety and efficacy of oral decitabine (ASTX727) and durvalumab (MEDI4736) combination therapy in the treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) who have progressed during or after treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 monotherapy for recurrent and/or metastatic disease. The clinical trial is studying drugs that can boost the participant's immune system against the cancer cells as a possible treatment for head and neck cancer. The study interventions involved in this study are: - Oral Decitabine (ASTX 727) - Durvalumab (MEDI4736)

NCT ID: NCT02921581 Active, not recruiting - Clinical trials for Head and Neck Cancer

ReIrradiation With FDG-PET Guided Dose Painting

RIDPAINT
Start date: June 2015
Phase: N/A
Study type: Interventional

Dose-painting may increase the chance of cure at minimised radiation-induced toxicity in intensity-modulated radiotherapy (IMRT) for primary head and neck cancer. This could also apply for recurrent and second primary head and neck cancers in previously irradiated volumes. This trial (RIDPAINT) investigates the feasibility of FDG-PET guided radiotherapy using IMRT dose-painting by contours for patients with recurrent and second primary head and neck cancer.

NCT ID: NCT02919683 Active, not recruiting - Clinical trials for Head and Neck Cancer

Window Study of Nivolumab With or Without Ipilimumab in Squamous Cell Carcinoma of the Oral Cavity

Start date: November 2016
Phase: Phase 2
Study type: Interventional

This research study is studying nivolumab, an investigational drug, in combination with ipilimumab, also an investigational drug, as a possible treatment for Squamous Cell Carcinoma of the oral cavity. The following drugs are involved in this study: - Nivolumab (Opdivo™) - Ipilimumab (Yervoy™)

NCT ID: NCT02918955 Active, not recruiting - Clinical trials for Head and Neck Neoplasms

Definitive Chemo-Radiotherapy for Regionally Advanced Head and Neck Cancer With or Without Up-front Neck Dissection

UPFRONT-NECK
Start date: October 2016
Phase: Phase 3
Study type: Interventional

Treatment of regionally-advanced head and neck squamous cell carcinoma (HNSCC) requires a multidisciplinary approach with a combination of surgery, radiotherapy (RT) and chemotherapy. Due to these aggressive combined modalities, patients undergoing treatment and many survivors develop toxicities which impact quality of life (QoL) and sometimes lead to mortality. Lymph node metastases of HNSCC are frequent and considered one of the most important prognostic factors, resulting in decreased survival by 50%. More than three decades, the optimal management strategy of node positive HNSCC was a key subject of debate. In summary, the current literature provides us two important findings: First, with the contemporary imaging and treatment modalities, there is no role of a planned neck dissection (ND) added to (chemo)radiotherapy ((C)RT) in terms of oncological outcome and survival. Second, with modern RT techniques, a tailored treatment followed after an up-front neck dissection (UFND) allows a significant reduction of treatment volumes and de-escalation of the dose to the neck, leading to reduction of treatment related toxicities. In this study strategies with and without up-front neck dissection prior to chemo-radiotherapy will be compared.

NCT ID: NCT02903875 Active, not recruiting - Clinical trials for Head and Neck Cancer

Therapeutic Education Program for Laryngectomised Patients and Their Close Relations

PETAL
Start date: April 2013
Phase: N/A
Study type: Observational

The therapeutic education of patients and their close relations is, as yet, poorly developed in France in the field of oncology, in particular for cancers of the upper aerodigestive tract. In the case of pharyngeal and laryngeal cancer, total laryngectomy associated with radiotherapy remains a reference treatment for advanced stage cancers. This mutilating surgical procedure has a major impact on the patient's life, due to its physical and functional sequelae. Its psychosocial consequences are also important, owing to the biographical disruption and the identity-related metamorphoses associated with illness and its treatment, which alter the quality of life not only of patients, but also of their close relations. Currently, care for laryngectomised patients consists essentially in informing and educating them on certain technical procedures during hospital admission. New voice education can be a long process and often involves the intervention of a speech therapist, who serves as the link between the patient and the hospital care team. These healthcare modalities often insufficiently account for the social, environmental and personal factors that interact in health-related problems. The aim is to design, implement and evaluate a patient therapeutic education (PTE) programme, for laryngectomised patients and their close relations, aimed at improving their quality of life. The research will be conducted over three phases: The first phase, referred to as the "pilot" phase, will include exploratory, observational and retrospective analysis aimed at developing knowledge on the consequences of laryngectomy on the quality of life of patients and their close relations, the strengths and weaknesses of current practice in patient support and the needs expressed by the players involved (patients, relations, professional carers). This analysis will be conducted via interviews with patients and their close relations and focus groups with the healthcare professionals involved in patient care and support (hospital and independent). This first phase will enable the pluridisciplinary design of a therapeutic education programme for laryngectomised patients and their close relations which will be tested in the study's principle coordinating centre. The method defined thus is in keeping with quality criteria set by the HAS specifying that the PTE should focus on the patient, be scientifically justified, and be developed by a pluridisciplinary group reuniting representatives of patients or patient associations. The second phase, referred to as the prospective intervention "replication" phase, aims at evaluating the programme's transferability and quality in three centres. The centres participating in this second phase already have experience in the development of PTE programmes and will be involved in the workgroup entrusted with the design of the PETAL programme during phase 1. The third phase, referred to as the "randomised" multicentric comparative intervention phase, should enable us to assess the benefits of the developed PTE programme on the quality of life of patients and their close relations. This is a pluridisciplinary study via which we hope to improve the quality of life of laryngectomised patients and their close relations through the design and the sustainable deployment of an innovative PTE programme in France and Belgium. This project also aims at reinforcing town-hospital links to improve help, follow-up and support for patients and their close relations, as well as dialogue between healthcare professionals.