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The psychosocial determinants of stress(vulnerablity) and cognitive complaints in breast cancer patients receiving elective radiotherapy

The primary aim of this study is to identify the psychosocial determinants of stress (vulnerability) and cognitive complaints in breast cancer patients treated with adjuvant radiotherapy. The stress model of Taylor and Aspinwall will be used.

Non invasive imaging of [18F] HX-4 with Positron-Emission-Tomography (PET): A phase I trial

To determine the toxicity of the hypoxia PET-tracer [18F]-HX4 in cancer patients.

Efficacy of a course "Living with head and neck cancer" in patients with head and neck cancer and their spouses

To obtain insight in the usefulness and efficacy of psychosocial intervention for HNC patients and their spouses by performing a pilot study

A European multicenter open-label study of breakthrough cancer pain: assessment of fentanyl buccal tablets titration and treatment in opioid-tolerant patients.

The primary objective is to compare the percentage of patients reaching an effective FBT dose with a starting dose of 100 mcg to those with a starting dose of 200 mcg. Secondary objectives are to evaluate the safety and tolerability and the…

prediction of survival in palliative patiënts with head neck cancer

Primary: development of a prognostic model for head and neck cancer patients in the palliative phase.Secundary: comparison of the prediction of the survival of palliative patients by the treating physician with both the prediction of the model as…

Efficacy of a course "Living with head and neck cancer" in patients with head and neck cancer and their spouses

To obtain insight in the usefulness and efficacy of psychosocial intervention for HNC patients and their spouses by performing a pilot study.

An early clinical feasibility study of a new prosthesis: the NewBreez® Intralaryngeal device; a possible solution for severe aspiration in head and neck cancer patients

This is a feasibility study to assess this new device after 6 months use. There are 3 objectives that have to be fulfilled in order use this device in the future:1. Safety of the NewBreez® at 6 months: has there been further damage done to the…

Phase-2 clinical trial on the treatment of chronic dysphagia in head and neck cancer patients with dedicated strengthening exercises using the Swallow Exercise Aid

Primary objective: effectiveness of the SEA exercises in HNC patients with chronic dysphagia, following an exercise protocol of 6 weeks.Secondary objective: feasibility/compliance of the SEA exercises in HNC patients with chronic dysphagia, during…

Influence of exercise and rest on pseudotumors.
MRI scanning of Metal-on-Metal total hip arthroplasy.

The influence of activity level right before the MRI is made is unknown. I seems clear that more activity results in more hydrops and so results in a larger pseudotumor. The objective of this study is to investigate the possible influence of timing…

Assessment of the responsiveness of the Rasch-built, CIPN-specific questionnaire (CIPN-RODS) to clinical changes in patients undergoing neurotoxic chemotherapy.

Primary Objective: to assess formally the responsiveness of a core set of measures derived from the previous CI-PeriNoms Study (Cavaletti, et al., 2013).Secondary objective: to test the responsiveness of the CIPN specific Rasch-built Overall…

Detection of aberrant androgen receptor transcripts in circulating tumour cells as a predictor of resistance to AR- directed treatment in patients with castration-resistant prostate cancer.

The objective of this study is to evaluate the clinical validation of a sensitive molecular assay to detect the presence of wild-type (so-called *full-length*) and alternatively spliced variants (ARV) of the AR in enriched CTC of patients with CRPC…

Longitudinal analysis of head and neck cancer-specific immunity in patients treated with (salvage) surgery

Aim of studyTo investigate whether patients with disease eligible for (salvage) surgery would potentially benefit from immunotherapy, we want to study the anti-tumor reactivity of T cells that have infiltrated the tumor. Infiltration of T cells in…

Lymphatic mapping of the neck in oral cavity malignancies using ICG-nanocolloid

Primary aim:Lymphatic mapping of the neck in oral cavity malignancies using ICG-nanocolloid. Secondary aims:- Analysis of lymphatic drainage of the head and neck area to determine the extension of the neck dissection.- Identification of the tumor…

IMAging with opto-acoustics to downgradE BI-RADS claSsificaTion Relative tO other diagnostic methodologies (MAESTRO)

This study is designed to determine whether the Imagio allows physicians to rapidly and effectively discern between benign and malignant masses with minimal potential side effects and therewith improve diagnostic efficiency. The study will evaluate…

A multicenter, open label, phase 1 dose escalation study to evaluate the pharmacokinetics, safety, and tolerability of INC280 tablet formulation with food in patients with cMET dysregulated advanced solid tumors

Primary: 1/ To determine the higher of the tolerated dose of INC280 tablets with food between 300 and 400 mg BID in patients with cMET dysregulated advanced solid tumors. 2/ To assess the PK of INC280 with food.Secondary: To assess the safety of…

A Phase 1 Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of HBM4003 in Subjects with Advanced Solid Tumors

Part 1: Dose-Escalation Stage (not in The Netherlands)Primary objective:* Safety and tolerability of HBM4003Secondary objectives:* Preliminary anti-tumor activities of HBM4003 in advanced solid tumors* Pharmacokinetics (PK) of HBM4003Other…

An open label, dose escalation followed by dose expansion, safety and tolerability trial of CAN04, a fully humanized monoclonal antibody against IL1RAP, in subjects with solid malignant tumors.

Primary ObjectivesPart I- To define the Maximum Tolerated Dose (MTD) or Recommended Phase 2 dose (RP2D) of CAN04 once weekly (Q1W) in subjects with relapsed or refractory NSCLC, PDAC, TNBC or CRC.Part II- To determine the safety and tolerability of…

A clinical phase I, open-label PET study with 89Zr CriPec docetaxel in patients with solid tumours to assess biodistribution and tumour accumulation of 89 Zr CriPec docetaxel

The primary objectives of this study is to determine whether uptake of 89Zr CriPec® docetaxel in tumour lesions can be detected and quantified

PREDICTIVE MODELS FOR RADIATION-INDUCED SIDE EFFECTS IN HEAD AND NECK CANCER BASED ON SINGLE NUCLEOTIDE POLYMORPHISMS (SNP)

The main objective of this project will be to test the hypothesis that SNP profiles can improve the performance of predictive models for the most frequently reported late RISE, i.e. dysphagia, in HNC patients after curative (CH) RT. Secondary…

Indocyanine green dye in surgical treatment of laryngeal cancer: perfusion assessment to identify patients at risk for complications

Primary Objective: We want to estimate cut off values for clinically appropriate hypoperfusion of the pharyngeal mucosa and the skin in the neck. Secondary Objective: We want to compare perfusion rate of PTL to perfusion rate in STL in order to…