Status:
COMPLETED
Postoperative Radiotherapy of Non-small Cell Lung Cancer: Accelerated vs. Conventional Fractionation
Lead Sponsor:
Technische Universität Dresden
Collaborating Sponsors:
German Consortium for Translational Cancer Research
National Center for Radiation Research in Oncology Dresden/Heidelberg
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 lo...
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 frac...
Eligibility Criteria
Inclusion
- histologically confirmed non-small cell lung cancer
- previous tumor resection with curative intention
- postoperative indication for irradiation (\> pN1 and/ or R1)
- R2-resection or recurrence postoperative/after adjuvant chemotherapy diagnosed by the restaging-imaging
- exclusion of distant metastases (M0)
- age \> 18 years
- good general condition (ECOG performance status 0 or 1)
- written informed consent
- appropriate compliance to ensure close follow-up
- women of childbearing age: adequate contraception
Exclusion
- histologically confirmed small cell lung cancer
- distant metastases
- no written informed consent or lack of cooperation relating to therapy or follow-up
- previous (\< 5 years) or concomitant other malignant disease (exception: malignant disease, which is very likely healed and not influenced therapy or follow up of the non-small cell lung cancer, e.g. carcinoma in-situ, basaliomas, very early skin cancers)
- for proton therapy: heart pacemaker
- previous radiotherapy of the thorax or lower neck region
- pregnancy or lactation
- participation in another intervention study or not completed follow-up of a intervention study. Exceptions are psychological studies, supportive or observation studies, the previous therapy of non-small cell lung cancer is in accordance with the guideline and the participation in radiotherapy studies is not excluded in the trial protocol of the previous study
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2020
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT02189967
Start Date
November 1 2014
End Date
July 1 2020
Last Update
July 22 2020
Active Locations (9)
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1
Universitätsklinikum Dresden, Department of Radiation Therapy and Radiation Oncology
Dresden, Germany, 01307
2
Universitätsklinikum Freiburg, Department of Radiation Therapy and Radiation Oncology
Freiburg im Breisgau, Germany, 79106
3
Praxis für Strahlentherapie Hamburg-Harburg
Hamburg, Germany, 21075
4
Universitätsklinikum des Saarlandes, Department of Radiotherapy and Radiation Oncology
Homburg, Germany