Postoperative Radiotherapy of Non-small Cell Lung Cancer: Accelerated vs. Conventional Fractionation
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ClinicalTrials.gov Identifier: NCT02189967 |
Recruitment Status :
Completed
First Posted : July 15, 2014
Last Update Posted : July 22, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-Small Cell Lung Cancer | Radiation: conventional fractionation Radiation: accelerated fraction | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 38 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Postoperative Radiotherapy of Non-small Cell Lung Cancer: Accelerated vs. Conventional Fractionation |
Actual Study Start Date : | November 2014 |
Actual Primary Completion Date : | August 2019 |
Actual Study Completion Date : | July 2020 |

Arm | Intervention/treatment |
---|---|
Active Comparator: conventional fractionation
radiotherapy with conventional fractionation (5 x 2Gy per week)
|
Radiation: 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. |
Active Comparator: accelerated fraction
radiotherapy with accelerated fraction (7 x 2 Gy per week)
|
Radiation: 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. |
- assessment of local tumor control [ Time Frame: 36 months after therapy ]Local tumor control will be assessed by appropriate non-invasive (CT or PET-CT) and if necessary invasive examination methods (bronchoscopy with biopsy).
- overall survival [ Time Frame: 36 months after therapy ]Follow-up visits should be continued in all patients until death. Otherwise patients will be censored with date of the last follow-up.
- local recurrence-free survival [ Time Frame: 36 months after therapy ]Local-recurrences will be assessed by appropriate non-invasive (CT or PET-CT) and if necessary invasive examination methods (bronchoscopy with biopsy).
- acute toxicity [ Time Frame: Comparison after 20, 50, 100 and 200 patients have been treated. This number of patients is expected to be included after 6, 12, 18 and 40 months. ]The occurrence of acute side effects (up to 90 days after start of treatment) will be recorded and documented based on CTCAE 4.0.
- quality of life [ Time Frame: 36 months after therapy ]The assessment of quality of life is carried out using the established EORTC QLQ-C30 questionnaire and the additional lung module QLQ-LC13. Quality of life will be documented immediately before the start of therapy, after completion of postoperative radiotherapy and at every follow-up visit.
- distant metastases-free survival [ Time Frame: 36 months after therapy ]Distant metastases will be assessed by PET-CT or abdominal sonography and chest x-ray.
- late toxicity [ Time Frame: Comparison after 20, 50, 100 and 200 patients have been treated. This number of patients is expected to be included after 6, 12, 18 and 40 months. ]The occurrence of late side effects will be recorded and documented based on CTCAE 4.0 after every follow-up visit.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189967
Germany | |
Universitätsklinikum Dresden, Department of Radiation Therapy and Radiation Oncology | |
Dresden, Germany, 01307 | |
Universitätsklinikum Freiburg, Department of Radiation Therapy and Radiation Oncology | |
Freiburg, Germany, 79106 | |
Praxis für Strahlentherapie Hamburg-Harburg | |
Hamburg, Germany, 21075 | |
Universitätsklinikum des Saarlandes, Department of Radiotherapy and Radiation Oncology | |
Homburg, Germany | |
Klinikum der Universität München,Department of Radiation Therapy and Radiation Oncology | |
München, Germany, 81377 | |
Klinikum rechts der Isar, Technische Universität München, Department of Radiation Therapy and Radiation Oncology | |
München, Germany, 81675 | |
Marienhospital Stuttgart, Department of Radiotherapy and Palliative Medicine | |
Stuttgart, Germany | |
Universitätsklinikum Tübingen, Department of Radiation Therapy and Radiation Oncology | |
Tübingen, Germany, 72016 | |
Poland | |
SPZOZ MSW; Warmia & Mazury Oncology Center; Warmia & Mazury Medical University | |
Olsztyn, Poland, 10-228 |
Principal Investigator: | Rebecca Bütof, Dr. | Dresden University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology |
Responsible Party: | Dr. Rebecca Bütof, Principal Investigator, Technische Universität Dresden |
ClinicalTrials.gov Identifier: | NCT02189967 |
Other Study ID Numbers: |
STR-PORTAF-2014 |
First Posted: | July 15, 2014 Key Record Dates |
Last Update Posted: | July 22, 2020 |
Last Verified: | July 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
non-small cell lung cancer radiotherapy accelerated fractionation conventional fractionation postoperative |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |