Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conventional fractionation | Active Comparator | radiotherapy with conventional fractionation (5 x 2Gy per week) |
|
| accelerated fraction | Active Comparator | radiotherapy with accelerated fraction (7 x 2 Gy per week) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| conventional fractionation | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| assessment of local tumor control | Local tumor control will be assessed by appropriate non-invasive (CT or PET-CT) and if necessary invasive examination methods (bronchoscopy with biopsy). | 36 months after therapy |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | Follow-up visits should be continued in all patients until death. Otherwise patients will be censored with date of the last follow-up. | 36 months after therapy |
| local recurrence-free survival |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rebecca Bütof, Dr. | Dresden University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Dresden, Department of Radiation Therapy and Radiation Oncology | Dresden | 01307 | Germany | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40663146 | Derived | 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. 2026 Mar;202(3):299-306. doi: 10.1007/s00066-025-02422-y. Epub 2025 Jul 15. | |
| 29262836 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| accelerated fraction | Radiation | In this treatment arm patients will receive radiotherapy with an accelerated fractionation schedule i.e. 7 fractions per week, 2 Gy single dose. |
|
Local-recurrences will be assessed by appropriate non-invasive (CT or PET-CT) and if necessary invasive examination methods (bronchoscopy with biopsy).
| 36 months after therapy |
| acute toxicity | The occurrence of acute side effects (up to 90 days after start of treatment) will be recorded and documented based on CTCAE 4.0. | 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. |
| quality of life | 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. | 36 months after therapy |
| distant metastases-free survival | Distant metastases will be assessed by PET-CT or abdominal sonography and chest x-ray. | 36 months after therapy |
| late toxicity | The occurrence of late side effects will be recorded and documented based on CTCAE 4.0 after every follow-up visit. | 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. |
| Universitätsklinikum Freiburg, Department of Radiation Therapy and Radiation Oncology |
| Freiburg im Breisgau |
| 79106 |
| Germany |
| Praxis für Strahlentherapie Hamburg-Harburg | Hamburg | 21075 | Germany |
| Universitätsklinikum des Saarlandes, Department of Radiotherapy and Radiation Oncology | Homburg | Germany |
| Klinikum der Universität München,Department of Radiation Therapy and Radiation Oncology | München | 81377 | Germany |
| Klinikum rechts der Isar, Technische Universität München, Department of Radiation Therapy and Radiation Oncology | München | 81675 | Germany |
| Marienhospital Stuttgart, Department of Radiotherapy and Palliative Medicine | Stuttgart | Germany |
| Universitätsklinikum Tübingen, Department of Radiation Therapy and Radiation Oncology | Tübingen | 72016 | Germany |
| SPZOZ MSW; Warmia & Mazury Oncology Center; Warmia & Mazury Medical University | Olsztyn | 10-228 | Poland |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided