O4. Central data collection of management NSCLC stage III patients—study ongoing
Milada Zemanova1, Karin Dieckmann2, Zuzana Zbozinkova3, Robert Pirker4, Lubos Petruzelka1
Background: Treatment of non-small cell lung carcinoma (NSCLC) stage III remains a challenge. Both local relapses and distant metastases are frequent, with 5-year survival often less than 20%. Management of locally advanced NSCLC represents a broad spectrum of treatment modalities combinations. There is evidence that management of stage III NSCLC varies between different countries and centres according to regional standards, facilities and resources. The aim of the study is to determine the actual standard management (diagnostic and therapeutic procedures) of patients with stage III NSCLC in Central European centres/countries.
Methods: Patients diagnosed with morphologically confirmed (cytology or histology) NSCLC in stage III according to UICC7. Patients of any age will be included in the project. This is a prospective multicenter international observational non-interventional study. The study is academically administered, with low budget, easily conducted. Participating centres will be registered by data manager from IBA MUNI after EC approval in each country. Data will be collected into electronic CRFs. Investigators will be asked to complete report forms for all consecutive patients diagnosed in stage III (including postoperative stage III being clinical stages I-II before surgery) in reference period. Planned study enrolment period is approximately 12 months, September 2014 to August 2015. Enrolment period for each centre will start at the date of centre registration (after EC approval). Duration of enrolment period for each centre is optional, maximum till end of overall study enrolment. Fundamental point is to enrol all consecutive stage III patients in selected period (full possible time or shorter). The data registration is fully anonymous, patient identification is in the responsibility of particular centre.
Results: Initiation of the study is planned for September 2014, participating countries Czech Republic and Austria, other participating centres will be included, with planned enrolment period September 2014 to August 2015.
Conclusions: Co-ordinators of the study ask new participating centres to register. Results will be used for education, publication and for clarification of future treatment ideas.
Keywords: Non-small cell lung carcinoma (NSCLC); stage III; chemoradiotherapy
doi: 10.3978/j.issn.2218-6751.2014.AB004