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Head and Neck Neoplasms clinical trials

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NCT ID: NCT03548727 Withdrawn - Clinical trials for Head and Neck Cancer

Pseudo-Simultaneous Imaging of Tumor Hypoxia and Proliferation in HNC Patients Using PET/CT

Start date: November 1, 2018
Phase: Early Phase 1
Study type: Interventional

66% of HNC patients present with advanced-stage disease at initial diagnosis. The 5-year survival rates for stages IVa, IVb, and IVc are 32%, 25%, and <4% respectively. Accurate pre-treatment staging is vital in determining the optimum procedure for the management of HNC. Early identification of non-responders may allow modification of their treatment through the introduction of more intensive therapies. Identifying prognostic factors that predict patient outcome will ultimately lead to new treatment regimens. Tumor hypoxia and proliferation are two key characteristics of cancer that were shown to correlate with poor response to treatment in HNC. In this proposal, the investigators assess the prognostic values of these two markers. Combining information from these two biological markers shall result in prognostic information superior to those of any of the two separately. Imaging those vital tumor characteristics simultaneously shall provide more coherent assessment of tumor microenvironment than does registration of corresponding images acquired in different imaging session, thus subject to uncertainties resulting from transient biologic changes and image registration process. The investigators propose to use a method that the investigators previously developed to simultaneously and non-invasively image tumor hypoxia (FMISO-PET) and proliferation (FLT-PET) within a single PET/CT study. CT Perfusion scan will be performed 1st, followed by PET imaging with staggered FMISO and FLT injections. FMISO and FLT signals will be separated retrospectively using kinetic modeling. The investigators believe imaging tumor hypoxia and cell proliferation simultaneously yield information underpinning for image-guided and radiobiological based dose painting, adaptive therapy, and patient medical management. If successful, this pilot study will constitute the basis for a NIH grant proposal that aims to improve treatment outcome assessment in HNC.

NCT ID: NCT03386838 Withdrawn - Clinical trials for Head and Neck Cancer

An Immuno-therapy Study of Nivolumab in Combination With Experimental Medication BMS-986205 Compared to Standard of Care EXTREME Regimen in First-line Recurrent/Metastatic Squamous Cell Carcinoma of Head and Neck

Start date: March 28, 2018
Phase: Phase 3
Study type: Interventional

This is a study of Nivolumab in combination with experimental medication BMS-986205 compared to the standard of care EXTREME regimen in head and neck cancer that has come back after initial treatment, or is widespread when first diagnosed.

NCT ID: NCT03372148 Withdrawn - Clinical trials for Head and Neck Cancer

Role of Pharyngeal High Resolution Manometry and Impedance in Swallow Function of Head and Neck Cancer Patients

Start date: December 2023
Phase: N/A
Study type: Interventional

Examining if the use of serial pHRMi to identify biomechanical changes in the swallow function of HNC patients treated with radiotherapy.

NCT ID: NCT03358095 Withdrawn - Pancreatic Cancer Clinical Trials

Cancer of the Head of the Pancreas: Early Surgery or Preoperative Biliary Drainage?

Start date: November 26, 2017
Phase: N/A
Study type: Interventional

Surgical resection is the only option for cure for patients with a resectable tumor located at the head of the pancreas. At the time of diagnosis, these patients often suffer from jaundice. Studies have suggested, that jaundice might increase the risk of developing a serious postoperative complication. Preoperative biliary drainage is widely used, because it is considered to improve the surgical outcome and reduce the amount of postoperative complications. There are also studies that suggest the opposite. In these studies the overall complication rate with patients who underwent preoperative biliary drainage was higher than in the patients who were operated right away. A significant amount of these complications were related to the biliary drainage process itself. However, preoperative biliary decompression is widely used in many centers as many surgical centers don't possess the needed resources to arrange early surgery. The benefits and risks of this procedure remain unclear. This multicenter trial aims to compare the surgical outcome and the rate of serious complications in patients who proceed directly to early surgery and patients who have preoperative biliary drainage.

NCT ID: NCT03345732 Withdrawn - Clinical trials for Head and Neck Cancer

Intraoperative Evaluation Using ICG and SPY Fluorescence to Prevent Wound Complications in Head and Neck Surgery.

Start date: December 8, 2016
Phase:
Study type: Observational

Wound complications, such as salivary-cutaneous fistulas and skin necrosis, result in significant patient morbidity and death. Head and neck wounds are complicated because of multiple tissue layers, critical structures and variable vascularity. When vascularity is compromised, wounds do not heal and can lead to life threatening haemorrhage or morbid infections. The field of microsurgical reconstruction has developed and expanded over the last 20 years to specifically ameliorate these issues. The challenge is that the vascularity of the microsurgical transplant or the recipient tissue bed can have areas of decreased vascularity that cannot be appreciated by the surgeon's intraoperative exam alone. Surgeons would be able to make better decisions with respect to the vascularity if there was an imaging technique that could indicate the vascular supply of the tissues undergoing surgical reconstruction. Laser-assisted indocyanine green fluorescent dye angiography (LA-ICG) using the SPY System (Novadaq Technologies Inc., Richmond, British Columbia, Canada) is an intraoperative vascular imaging technique that improves the ability of a surgeon to assess the vascular supply in the surgical bed. This tool, which is approved by Health Canada for reconstructive surgery, has been used extensively in breast reconstruction and gastrointestinal procedures with encouraging results. The ability to address ischemic tissues intraoperatively could potentially decrease the rate of devastating wound complications in head and neck surgery patients. The objective of this observational study is to assess the effectiveness of LA-ICG in head and neck reconstructive procedures to reduce the rate of skin necrosis and fistula.

NCT ID: NCT03261180 Withdrawn - Clinical trials for Head and Neck Carcinoma

Nestle Impact Advanced Recovery in Improving Surgery Recovery in Patients With Head and Neck Cancer

Start date: November 30, 2017
Phase: N/A
Study type: Interventional

This randomized clinical trial studies how well Nestle Impact Advanced Recovery works in improving surgery recovery in patients with head and neck cancer. Adding a nutritional supplement, such as Nestle Impact Advanced Recovery to a regular diet before and after head and neck cancer surgery may help to decrease the number of wound complications after surgery.

NCT ID: NCT03238638 Withdrawn - Clinical trials for Head and Neck Cancer

A Study of Epacadostat + Pembrolizumab in Head and Neck Cancer Patients, Who Failed Prior PD-1/PD-L1 Therapy

Start date: September 2018
Phase: Phase 2
Study type: Interventional

This is a research study to test the combination of two drugs, pembrolizumab and epacadostat with the goal of benefiting subjects with head and neck cancers where prior or ongoing regimens with a PD-1 or PD-L1 inhibitor for the treatment of advanced head and neck cancer after platinum failure.

NCT ID: NCT02993991 Withdrawn - Clinical trials for Squamous Cell Carcinoma, Head And Neck

Pre-operative Mocetinostat (MGCD0103) and Durvalumab (MEDI4736) (PRIMED) for Squamous Cell Carcinoma of the Oral Cavity

PRIMED-001
Start date: October 10, 2017
Phase: Phase 1
Study type: Interventional

This is a Phase 1 Window of Opportunity study to evaluate the pharmacodynamic and immune effects of pre-operative therapy with Mocetinostat and Durvalumab on patients with squamous cell carcinoma of the oral cavity.

NCT ID: NCT02984033 Withdrawn - Quality of Life Clinical Trials

Quality of Life and Psycological Evaluation of Patients Affected by Head and Neck Cancer

Start date: November 2016
Phase:
Study type: Observational

The prospective trial is to describe the quality of life and psychological effects in patients with head and neck tumor receiving curative intent treatment

NCT ID: NCT02908386 Withdrawn - Clinical trials for Head and Neck Neoplasms

ROCOCO - Adaptive IMRT Versus IMPT in Head and Neck Cancer

ROCOCO
Start date: November 2015
Phase: N/A
Study type: Observational

Given the lack of evidence for the benefit of particle therapy in relevant cases, he investigators proposed an in silico trial to investigate the dosimetric effect of contour changes for OAR as well as tumor during chemoradiation in H&N patients. Photon and proton-therapy will be compared based on dosimetric data on 7 time points during treatment combined with plan robustness. In that way the investigators will be able to assess and compare the optimal timing for replanning for photon and proton therapy. A database of the University of Pennsylvania (Upenn) consists of 10 patients with head and neck tumors treated with chemo-radiation. Contrast-enhanced CT scans were acquired prior and during RT (T1-T7)