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Head and Neck Neoplasms clinical trials

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NCT ID: NCT03067610 Completed - Clinical trials for Head and Neck Cancer

Involved Field Elective Volume De-Intensification Radiation Therapy for Head and Neck Cancer

INFIELD
Start date: January 20, 2017
Phase: Phase 2
Study type: Interventional

Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel)

NCT ID: NCT03065634 Terminated - Clinical trials for Head and Neck Cancer

Return to Work and Living Healthy After Head and Neck Cancer

RELIANCE
Start date: January 1, 2017
Phase: N/A
Study type: Interventional

Based on a randomized controlled trial, the manualized group intervention Return to work and living healthy after head and neck cancer (RELIANCE) for head and neck cancer survivors will be tested against a non-manualized control intervention (social counseling) in order to evaluate the efficacy of the RELIANCE intervention compared to the control condition. The study design includes two phases, the initial study phase (pilot study) and the intervention study (RCT). The aim of the pilot study is to implement and ensure the necessary standardized procedures for the implementation of patient recruitment and interventions. In the randomized controlled trial, potential participants are assigned to the intervention group or to the control group.

NCT ID: NCT03065062 Recruiting - Pancreatic Cancer Clinical Trials

Study of the CDK4/6 Inhibitor Palbociclib (PD-0332991) in Combination With the PI3K/mTOR Inhibitor Gedatolisib (PF-05212384) for Patients With Advanced Squamous Cell Lung, Pancreatic, Head & Neck and Other Solid Tumors

Start date: February 28, 2017
Phase: Phase 1
Study type: Interventional

This research study is studying a combination of drugs as a possible treatment for cancer that might have a specific change in the phosphatidylinositol-3 phosphate (PI3K) pathway.

NCT ID: NCT03057613 Completed - Clinical trials for Squamous Cell Carcinoma of the Head and Neck

The Addition of Pembrolizumab to Postoperative Radiotherapy in Cutaneous Squamous Cell Cancer of the Head and Neck

Start date: May 10, 2017
Phase: Phase 2
Study type: Interventional

A small group of skin cancers of the head and neck, called resected cutaneous squamous carcinomas, are more aggressive than most cancers of this type, even after being treated with standard therapy. This trial will use stronger treatment to look at the safety and effectiveness (efficacy) of combining a drug called Pembrolizumab with radiation after a cancer has already been treated to suppress secondary tumor formation in high risk cutaneous squamous cell cancer of the head and neck. Primary Objective To assess safety by looking at the people with dose limiting responses

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: NCT03053310 Recruiting - Head and Neck Clinical Trials

Value of Geriatric Screening to Predict Postoperative Morbidity for Head and Neck Cancer

GEROP
Start date: January 25, 2017
Phase:
Study type: Observational

Background Approximately half of head and neck cancer patients are 65 years or older at diagnosis. Treatment decisions in this older HNCA population are challenging, because of the lack of evidence-based guidelines. Surgery is often the treatment of choice in a HNCA setting where curative treatment is intended. Though chronological age per se has not been reported as a contraindication for surgery, data are limited and often the result of retrospective studies. Measurement of functional age, through a comprehensive geriatric assessment, has been suggested by several international cancer organizations to be a better prognostic indicator. At the divisions of maxillofacial surgery and otorhinolaryngology, a geriatric assessment is part of routine preoperative staging for patients of 70 years old or older. Objectives The investigators aim to determine the value of G8 to predict 30-day postoperative comorbidity in an older HNCA population undergoing elective curative surgery. Moreover, they aim to examine the vulnerability profile of patients undergoing elective head and neck surgery for an oncology diagnosis. Study design All patients of 70 years and older, presenting at the divisions of maxillofacial surgery and otorhinolaryngology for curative surgery of a solid head and neck tumour undergo a geriatric consult as part of routine preoperative staging. The presence of postoperative morbidity and mortality within the first 30 days after surgery will be collected as a primary endpoint. At 30±10 days postoperative, all patients will be re-evaluated with the G8 and the CGA. Patient' quality of life will also be re-examined within 30 days postoperative and again at 6 and 12 months postoperative. Conclusion There is still no consensus whether older HNCA patients should receive a different treatment compared to younger patients. Data related to the vulnerability profile of older patients requiring HN surgery, and the predictive value of geriatric screening for postoperative morbidity could enable better patient selection in the future.

NCT ID: NCT03051906 Not yet recruiting - Clinical trials for Head and Neck Neoplasms

Durvalumab, Cetuximab and Radiotherapy in Head Neck Cancer

DUCRO-HN
Start date: January 2018
Phase: Phase 1/Phase 2
Study type: Interventional

In over 60% of cases, squamous cell carcinoma of the head and neck (SCCHN) is discovered at a loco-regionally advanced stage that requires a combined multimodal strategy in order to pursue a curative intent. Bonner et al demonstrated that the combination of radiation (RT) with Cetuximab (CTX), a chimeric mouse IgG1 monoclonal anti-EGFR antibody, results in better median locoregional control and overall survival compared with RT alone without an increased rate of > G3 acute toxicity or detrimental effect on compliance and quality of life. However, subsequent negative trials (RTOG 0522) led to the hypothesis that in unselected patient populations the benefit of CTX may be diluted due to the molecular heterogeneity of SSCHN. Moreover, the absence of biomarkers predictive of response to anti-EGFR treatment may in part be explained by the observation that other factors play a role in favoring its anticancer effect, namely immunologic mechanisms. It has been demonstrated that SCCHN is an immunosuppressive disease characterized by prominent immuno-escape mechanisms, such as induction of a tumor-permissive cytokine profile and qualitative/quantitative lymphocyte deficiencies, occurrence of anergy in major immune effector cells and poor antigen presentation. Given these observations, it has been postulated that SCCHN may benefit from immunotherapeutic strategies, primarily aimed at PD-L1/PD1 checkpoint blockade. Segal et al (Asco 2015) reported preliminary results on the use of Durvalumab in pretreated patients with recurrent/metastatic SCCHN. Durvalumab is a humanized monoclonal IgG1 antibody that blocks PD-L1 binding to PD-1 and CD80 with high affinity and selectivity, thereby promoting activity of tumor-specific effector T cells and global anti-tumor immune response. Out of 64 treated patients, 51 patients were available for the preliminary efficacy analysis: promisingly, the overall response rate was 12% (25% in PD-L1 positive patients). To date, no clinical trial, specifically designed for SCCHN, testing PD-L1 targeted agents has been completed, nor have been initiated combination strategies of CTX, RT and PD1/PD-L1 antibodies in the curative setting. Taken all data together, a strong rationale may support the combination of Durvalumab, anti-EGFR therapy such as CTX and RT in order to revert the SCCHN-induced immune suppression and maximize treatment efficacy, ultimately through enhanced, CTX-mediated immune mechanisms and maximized RT-specific cytotoxicity.

NCT ID: NCT03051269 Recruiting - Head Neck Cancer Clinical Trials

Calcium Electroporation for Head and Neck Cancer

Start date: May 2016
Phase: Phase 1
Study type: Interventional

In a phase I protocol to primarily investigate the safety of using calcium combined with electroporation on recurrent head and neck cancers. Secondly, to evaluate tumour response on PET/MRI (positron emission tomography/magnetic resonance imaging), clinical evaluation, biopsies. Thirdly, to evaluate the effect of calcium electroporation compared to electrochemotherapy as well as the patients life-of-quality through questionnaires, EORTC QLQ C-30 and H&N35 (european organisation for research and treatment of cancer).

NCT ID: NCT03047174 Completed - Clinical trials for Head and Neck Neoplasms

Radiotherapy Related Skin Toxicity: Mepitel® vs. Standard Care in Patients With Locally Advanced Head-and-Neck Cancer

RAREST-01
Start date: May 9, 2017
Phase: N/A
Study type: Interventional

The aim for the present study named RAREST (RAdiotherapy RElated Skin Toxicity) is to compare the new dressing with the standard skin care. 168 patients receiving radiotherapy alone or radiochemotherapy for locally advanced head-and-neck cancer will be included. The primary aim is to investigate the rate of patients experiencing severe, stressful radiation dermatitis. The skin status will daily be inspected and assessed by specially trained doctors and nursing staff. It is expected that the new self-adhesive dressing is superior to standard care with respect to prevention of grade ≥2 radiation dermatitis in patients receiving radiotherapy or radio(chemo)therapy for a head-and-neck tumor. Thus, the dressing would be well qualified to become a new standard procedure at the skin care of patients with a head-neck tumor.

NCT ID: NCT03042195 Completed - Clinical trials for Head and Neck Neoplasm

Supplementary Postoperative Parenteral Nutrition for Head and Neck Cancer Patients

SpPN-HNC
Start date: December 18, 2016
Phase: N/A
Study type: Interventional

The purpose of the study is to examine whether postoperative nutrition with endeavours of 100% coverage of the patient's estimated energy and protein needs, can reduce the incidence of postoperative complications.