About project

Project description

The project has been designed as a retrospective data collection in a locally run database system, which fulfills the requirements on the basic version of electronic medical records of cancer patients. The diagnostic category of head and neck tumours has been selected on purpose, as it presents a major problem in the Comprehensive Cancer Centre of Ostrava, and it is relevant given the high incidence and mortality in the Moravian-Silesian Region. The parametric and logically organized system monitors the diagnostic identification of cancer, basic set of prognostic factors, treatment procedure and results, as well as a detailed record of complications and risk events.

The target parameters of the assessment include short-term as well as long-term treatment results in patients with head and neck tumours, evaluated with standard indicators of treatment response and survival. A special emphasis is put on major treatment modalities, i.e. surgery and radiation therapy, and on related complications. The informational background of the project is ensured with an open an on-line available system, which will offer the cooperation with other health care facilities in the Czech Republic (after the initial phase of the project). The project results will contribute methodically to the exact evaluation of the diagnostics and treatment of patients with head and neck cancer and will help to optimize the medical care.

Initial conditions

The incidence of head and neck cancer in the Moravian-Silesian Region is very high. Given that the treatment results are unsatisfactory, new and better means of medical care are being searched. The main treatment methods involve surgery and radiation therapy. The latter may be used in combination with chemotherapy. The major problem of treatment efficiency is the local control of the disease: the local relapse is the most frequent cause of failure of curative therapy. The radiation therapy of head and neck tumours is extremely demanding as for the accuracy and precision; recent improvements in radiotherapy techniques allow to apply a higher radiation dose on a tumour, while the surrounding healthy tissues are relatively spared.

In 2002 – 2005, the Institute of Biostatistics and Analyses of the Masaryk University has developed a basic structure of parametric documentation for cancer patients. This methods & data standard has been implemented in an on-line available database and it is possible to use it for both local and multicentre projects. The specific adaptation of this product for head and neck cancer will contribute to the development of a methodical standard for such clinical monitoring. The implementation in the Faculty Hospital of Ostrava will subsequently help to parametrize the hospital information system.

Project objectives

1. To establish a parametric documentation for patients with head and neck tumours and to make it work in the form of an anonymized clinical registry in the Faculty Hospital of Ostrava.
2. To establish an analytical reporting over the collected data.
3. To enhance the feedback of doctors to the patients' data.
4. To improve the treatment results in patients with head and neck tumours, in terms of decreasing the percentage of local relapses and improving disease free survival and overall survival.

Plans for project realization

The project has been scheduled to the period 2007 – 2008. Apart from the data collection itself, the realization of the project involves other research subprojects and activities:

1. Retrospective evaluation of treatment results in radiation therapy of head and neck tumours in the last two years on the Department of Oncology. Analysis of causes of treatment failures.
2. Introduction of new techniques of radiation therapy (accelerated radiotherapy, intensity-modulated radiation therapy, image-guided radiation therapy) and a stricter multi-level quality control in radiotherapy procedures. Prospective monitoring of parameters concerning the patient and the treatment.
3. Initiation of a new, non-commercial clinical trial of phase I/II, entitled "Combination of celecoxib (cyclooxygenase 2 inhibitor) with radiotherapy in the treatment of advanced head and neck tumours" (an application for a IGA grant has been submitted). After the recruitment of 25-30 patients, the maximum tolerated dose of celecoxib will be evaluated, along with the treatment toxicity and preliminary treatment results. Depending on the outcome, a clinical trial of phase II may be initiated. The quality of the clinical trial will be continuously monitored by a professional team and subjected to an independent audit.
4. After cca one-year prospective monitoring of patients treated with standard methods (apart from the clinical trial mentioned above), the treatment results will be compared with historic control subjects (see point 1). The results will be analysed and a target for the next period will be set.

Anticipated benefits of the project

HardRock is a pilot project which - if it proves to be succesful - might be extended to other frequent diagnoses in the Comprehensive Cancer Centre of the University Hospital of Ostrava (colorectal carcinoma, prostate carcinoma, malignant lymphomas etc.). The project will provide an objective evaluation of treatment results, help to identify the causes of therapy failures, and facilitate the research of a new treatment procedure (clinical trial). Since radiation therapy is the key method to treat head and neck tumours, the comparison of the acquired data with historic controls will provide an exact assessment of radiotherapy quality and suggest means of further improvements.

In Ostrava, 20.1.2007	In Brno, 20.1.2007
David Feltl, MD, Ph.D.	Assoc. Prof. Ladislav Dušek, Ph.D.
Head of the Department of Oncology of the University Hospital of Ostrava	Director of the Institute of Biostatistics and Analyses
Head of the Comprehensive Cancer Centre of Ostrava	Masaryk University, Brno