Postoperative Radiotherapy of Non-small Cell Lung Cancer: Accelerated vs. Conventional Fractionation
NCT ID: NCT02189967
Last Updated: 2020-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
38 participants
INTERVENTIONAL
2014-11-30
2020-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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conventional fractionation
radiotherapy with conventional fractionation (5 x 2Gy per week)
conventional fractionation
In this treatment arm patients will receive radiotherapy with the currently used conventional fractionation schedule i.e. 5 fractions per week, 2 Gy single dose.
accelerated fraction
radiotherapy with accelerated fraction (7 x 2 Gy per week)
accelerated fraction
In this treatment arm patients will receive radiotherapy with an accelerated fractionation schedule i.e. 7 fractions per week, 2 Gy single dose.
Interventions
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conventional fractionation
In this treatment arm patients will receive radiotherapy with the currently used conventional fractionation schedule i.e. 5 fractions per week, 2 Gy single dose.
accelerated fraction
In this treatment arm patients will receive radiotherapy with an accelerated fractionation schedule i.e. 7 fractions per week, 2 Gy single dose.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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German Consortium for Translational Cancer Research
OTHER
National Center for Radiation Research in Oncology Dresden/Heidelberg
OTHER
Radiation Oncology Working Group of the German Cancer Society
OTHER
Technische Universität Dresden
OTHER
Responsible Party
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Dr. Rebecca Bütof
Principal Investigator
Principal Investigators
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Rebecca Bütof, Dr.
Role: PRINCIPAL_INVESTIGATOR
Dresden University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology
Locations
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Universitätsklinikum Dresden, Department of Radiation Therapy and Radiation Oncology
Dresden, , Germany
Universitätsklinikum Freiburg, Department of Radiation Therapy and Radiation Oncology
Freiburg im Breisgau, , 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
Countries
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References
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Butof R, Koi L, Lock S, Appold S, Drewes S, Koschel D, Kotzerke J, Nestle U, Adebahr S, Zips D, Heinzelmann F, Hehr T, Bucher D, Heide J, Belka C, Manapov F, Wasilewska-Tesluk E, Fleckenstein J, Krause M, Troost EGC, Baumann M. Accelerated vs. conventionally fractionated postoperative radiotherapy of non-small cell lung cancer-final results of the prematurely terminated PORTAF trial. Strahlenther Onkol. 2025 Jul 15. doi: 10.1007/s00066-025-02422-y. Online ahead of print.
Butof R, Simon M, Lock S, Troost EGC, Appold S, Krause M, Baumann M. PORTAF - postoperative radiotherapy of non-small cell lung cancer: accelerated versus conventional fractionation - study protocol for a randomized controlled trial. Trials. 2017 Dec 20;18(1):608. doi: 10.1186/s13063-017-2346-0.
Other Identifiers
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STR-PORTAF-2014
Identifier Type: -
Identifier Source: org_study_id
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