Hypoxia Analysis in Head and/or Neck Cancer
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|ClinicalTrials.gov Identifier: NCT02414048|
Recruitment Status : Recruiting
First Posted : April 10, 2015
Last Update Posted : June 17, 2016
The primary objective is the prospective determination of disease-specific and overall survival in head and neck cancer patients who have undergone surgery, correlated to non-invasive methods of measuring tumour hypoxia.
The secondary objective is to define tumour hypoxia using non-invasive methodology.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: Pimonidazole||Phase 2|
The incidence of head and neck squamous cell cancer (HNSCC) is around 600 000 cases per year worldwide. The main sites for HNSCC are the larynx, the pharynx and the oral cavity. Head and neck cancers, however, also include salivary gland tumours, as well as nasopharyngeal cancer and paranasal and nasal sinus cancer but these are rare. The major risk factors are smoking, alcohol abuse and Human Papillomavirus (HPV) infection. In spite of radical surgical treatment and aggressive neo-adjuvant and adjuvant therapies, the prognosis of head and neck cancer is very poor due to the fact that the tumours are often hypoxic.
Tumour hypoxia is heterogenous and results from an imbalance between oxygen supply and oxygen consumption. Acute hypoxia is caused by abnormal structure and function of the microvasculature supplying the tumour. Chronic hypoxia is caused by the increased distance through which the oxygen has to diffuse to get from the blood vessels to the tumour cells and by the reduced oxygen caused by the anaemia which can be treatment or disease-related. These hypoxic regions have been shown to affect the metabolism of the cells, making them more aggressive with increased risk of metastasis and a worse prognosis. Also, because radiotherapy relies on oxygen to cause maximal cytotoxicity, a lack of oxygen to the cells or even a lack of oxygen consumption by the cells would cause a decrease in the effectiveness of the radiotherapy and the cytotoxicity. Hypoxic cells have an acidic environment which affects drug delivery and drug activity, so chemotherapy is compromised.
In order to predict outcome and identify patients with a worse prognosis or patients that would benefit from appropriate treatments, in vivo measurement of tumour hypoxia is required. Numerous methods have been explored but there is no accepted gold standard. Imaging and biomarker analysis have been shown to have potential but the data are insufficient. In this project the investigators would prospectively use existing imaging techniques and analysis of various bodily fluids to predict outcome. This is a collaboration between 5 different departments so that as much information as possible can be analysed and used to come to a possible solution.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Predictive Methods Determining Tumour Hypoxia in Head and Neck Cancer Patients - a Prospective Project|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||October 2022|
|Estimated Study Completion Date :||October 2022|
All patients will receive Pimonidazole to demarcate hypoxia regions in the tumour
Pimonidazole will be administered orally and will serve to demarcate the hypoxic areas in the tumour
Other Name: Oral Hypoxyprobe
- Disease-specific and overall survival correlated with tumour hypoxia [ Time Frame: 5-years ]Tumour hypoxia will be determined from the Pimonidazole staining and this will be correlated to disease-specific survival and overall survival. The study has been approved for 10 participants to be increased by the ethical committee to 100 once the study is going.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02414048
|Contact: Christine Hageremail@example.com|
|Department of Cranio-, Maxillofacial and Oral Surgery||Recruiting|
|Zürich, Switzerland, 8090|
|Contact: Christine Hager firstname.lastname@example.org|
|Principal Investigator:||Marius Bredell||Department of Cranio-, Maxillofacial and Oral Surgery, University Hospital Zurich|