Research and projectsContract research projects

Contract research projects Corect

Duration Duration: 2011–2018

Contracting authority Contracting authority: Czech Society for Oncology

Clinical registry of colorectal cancer (CRC) patients who have been treated with cetuximab (Erbitux®), bevacizumab (Avastin®) and/or panitumumab (Vectibix®).

Colorectal cancer (CRC) is among the most commonly diagnosed cancers and its incidence rates in all developed countries are growing steadily. Unfortunately, the Czech Republic ranks among the countries with highest colorectal cancer incidence rates worldwide. According to the latest data from GLOBOCAN 2012, Czech male colorectal cancer incidence rates rank 3rd in Europe after Slovakia and Hungary, while female rates rank 10th in Europe. The population burden is very high indeed: each year around 8,000 patients are diagnosed with colorectal cancer in the Czech Republic, and the number of CRC deaths is about 4,000.

Despite the high incidence of the disease, more and more patients can be successfully treated thanks to ongoing improvements in diagnosis and treatment methods. Targeted therapies are known to affect cancer cells in a selective manner and to stop tumour growth, raising hopes for even more successful treatments of many types of cancer, including the metastatic colorectal cancer (mCRC).

The Corect registry focuses on the collection of epidemiological and clinical data on mCRC patients treated with targeted therapies in the Czech Republic.

Over the last few years, the number of targeted therapies for colorectal cancer has gradually risen, and so has the number of Czech drug registries which have been launched to monitor treatment of mCRC with individual targeted drugs; namely Erbitux and Avastin (part of the registry dealing with mCRC), which monitored treatment with cetuximab (Erbitux®) and bevacizumab (Avastin®), respectively. The Board of the Czech Society for Oncology has therefore agreed to solve this complicated situation by creating a new unified registry which would integrate all data collected so far within original registries. Apart from drugs which were previously monitored in the above-mentioned registries, the Corect registry will also monitor treatment with panitumumab (Vectibix®) – a new targeted therapy which has become available only recently. If a new drug is approved by health care payers for targeted mCRC treatment, it can be easily integrated into the Corect registry.

Data collected previously in the above-mentioned registries have been transferred into the Corect registry. This procedure has eliminated the necessity of entering data on treatment of any given mCRC patient into several different registries; moreover, coherent and well-arranged information has been obtained on the overall treatment of that patient, the potential sequence of targeted therapies, and the patient’s response to treatment. The new project has therefore not only improved the quality of collected data, but also simplified the work for registry users. Apart from providing epidemiological characteristics of mCRC patients, the registry also enables researchers to assess risk factors on patients’ survival and to analyze adverse effects. The registry can also be used to make pharmacoeconomic assessments such as planning costs for cancer therapy. The project was initiated in April 2011 at the Institute of Biostatistics and Analyses of the Masaryk University (IBA MU) and has continued at the Institute of Biostatistics and Analyses Ltd (IBA Ltd), a university company.

Primary objective of the project:

  • monitoring the overall number of mCRC patients in the Czech Republic treated with cetuximab, bevacizumab and panitumumab.

Secondary objectives of the project:

  • assessment of effectiveness of targeted therapies in routine clinical practice (separately for each line of treatment):
    • overall survival, defined as the period from the start of treatment by a given drug to a patient’s death (surviving patients will be censored with respect to the date of last treatment assessment, loss to follow-up, or end of study),
    • progression-free survival, defined as the period from the start of treatment by a given drug to disease progression or death,
    • patients’ response to treatment (complete response, partial response, disease stabilisation, disease progression according to RECIST - Response Evaluation Criteria In Solid Tumors)
  • assessment of profile of targeted therapies in everyday clinical practice,
  • epidemiological analysis of records on mCRC patients.

Other important information:

  • Expert guarantor: Katarína Petráková, MD, PhD (Czech Society for Oncology)
  • Partners: 20 cancer centres in the Czech Republic (you can find more detailed information on the website of the Corect project)
  • Brief overview of results: you can find more detailed information on the website of the Corect project
Corect: Clinical registry of colorectal cancer (CRC) patients who have been treated with cetuximab, bevacizumab and/or panitumumab