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Brief Title: Postoperative Radiotherapy of Non-small Cell Lung Cancer: Accelerated vs. Conventional Fractionation
Official Title: Postoperative Radiotherapy of Non-small Cell Lung Cancer: Accelerated vs. Conventional Fractionation
Study ID: NCT02189967
Brief Summary: In this randomized multicentric phase II study it will be investigated whether an accelerated postoperative radiotherapy with photons or protons (7 fractions per week, 2 Gy single dose) may improve locoregional tumour control in non-small cell lung cancer (NSCLC) in comparison to conventional fractionation (5 fractions per week, 2 Gy single dose).
Detailed Description: This study is a randomized multicentric trial. Within this study an accelerated irradiation schedule (7 fractions per week, 2 Gy single dose) will be compared with the currently used conventional fractionation schedule (5 fractions per week, 2 Gy single dose) for postoperative radiotherapy with photons or protons in patients with NSCLC. The primary endpoint is locoregional tumour control after 36 months. Secondary endpoints are overall survival of patients, local recurrence-free and distant metastases-free survival after 36 months, acute and late toxicity as well as quality of life for both treatment methods.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Universitätsklinikum Dresden, Department of Radiation Therapy and Radiation Oncology, Dresden, , Germany
Universitätsklinikum Freiburg, Department of Radiation Therapy and Radiation Oncology, Freiburg, , Germany
Praxis für Strahlentherapie Hamburg-Harburg, Hamburg, , Germany
Universitätsklinikum des Saarlandes, Department of Radiotherapy and Radiation Oncology, Homburg, , Germany
Klinikum der Universität München,Department of Radiation Therapy and Radiation Oncology, München, , Germany
Klinikum rechts der Isar, Technische Universität München, Department of Radiation Therapy and Radiation Oncology, München, , Germany
Marienhospital Stuttgart, Department of Radiotherapy and Palliative Medicine, Stuttgart, , Germany
Universitätsklinikum Tübingen, Department of Radiation Therapy and Radiation Oncology, Tübingen, , Germany
SPZOZ MSW; Warmia & Mazury Oncology Center; Warmia & Mazury Medical University, Olsztyn, , Poland
Name: Rebecca Bütof, Dr.
Affiliation: Dresden University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology
Role: PRINCIPAL_INVESTIGATOR