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Postoperative Radiotherapy of Non-small Cell Lung Cancer: Accelerated vs. Conventional Fractionation

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ClinicalTrials.gov Identifier: NCT02189967
Recruitment Status : Recruiting
First Posted : July 15, 2014
Last Update Posted : February 8, 2019
Sponsor:
Collaborators:
German Consortium for Translational Cancer Research
National Center for Radiation Research in Oncology Dresden/Heidelberg
Radiation Oncology Working Group of the German Cancer Society
Information provided by (Responsible Party):
Dr. Rebecca Bütof, Technische Universität Dresden

Study Description
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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).

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Radiation: conventional fractionation Radiation: accelerated fraction Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 308 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
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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.


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

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Rebecca Bütof, Dr. +49 351 458 2238 str.studien@uniklinikum-dresden.de

Locations
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Germany
Universitätsklinikum Dresden, Department of Radiation Therapy and Radiation Oncology Recruiting
Dresden, Germany, 01307
Contact: Michael Baumann, Prof.    +49 351 458 2238    str.studien@uniklinikum-dresden.de   
Principal Investigator: Michael Baumann, Prof.         
Universitätsklinikum Erlangen, Department of Radiation Therapy and Radiation Oncology Not yet recruiting
Erlangen, Germany, 91054
Contact: Rainer Fietkau, Prof.    +49 9131 85 33405      
Principal Investigator: Rainer Fietkau, Prof.         
Universitätsklinikum Freiburg, Department of Radiation Therapy and Radiation Oncology Recruiting
Freiburg, Germany, 79106
Contact: Anca Grosu, Prof.    +49 761 270 94610      
Principal Investigator: Anca Grosu, Prof.         
Universitätsklinikum Halle (Saale), Department of Radiation Therapy and Radiation Oncology Not yet recruiting
Halle, Germany, 06110
Contact: Dirk Vordermark, Prof.    +49 345 557 4310      
Principal Investigator: Dirk Vordermark, Prof.         
Praxis für Strahlentherapie Hamburg-Harburg Recruiting
Hamburg, Germany, 21075
Contact: Jürgen Heide, Dr.         
Contact: Jürgen Heide, Dr.    040 / 866 910-80    info@strahlentherapie-harburg.de   
Universitätsklinikum Heidelberg, Department of Radiation Therapy and Radiation Oncology Not yet recruiting
Heidelberg, Germany, 69120
Contact: Jürgen Debus, Prof.    +49 6221 / 56 82 01      
Principal Investigator: Jürgen Debus, Prof.         
Universitätsklinikum des Saarlandes, Department of Radiotherapy and Radiation Oncology Recruiting
Homburg, Germany
Contact: Christian Rübe, Prof.       radioonkologie@uks.eu   
Universitätsmedizin Mainz, Department of Radiation Therapy and Radiation Oncology Not yet recruiting
Mainz, Germany, 55131
Contact: Heinz Schmidberger, Prof.    +49 6131 17-3851      
Principal Investigator: Heinz Schmidberger, Prof.         
Klinikum der Universität München,Department of Radiation Therapy and Radiation Oncology Recruiting
München, Germany, 81377
Contact: Claus Belka, Prof.    +49 89 7095 4520      
Principal Investigator: Claus Belka, Prof.         
Klinikum rechts der Isar, Technische Universität München, Department of Radiation Therapy and Radiation Oncology Active, not recruiting
München, Germany, 81675
Universitätsmedizin Rostock, Department of Radiation Therapy and Radiation Oncology Not yet recruiting
Rostock, Germany, 18059
Contact: Guido Hildebrandt, Prof.    +49 0381 - 494 9000      
Principal Investigator: Guido Hildebrandt, Prof.         
Marienhospital Stuttgart, Department of Radiotherapy and Palliative Medicine Recruiting
Stuttgart, Germany
Contact: Thomas Hehr, Prof.       strahlentherapie@vinzenz.de   
Universitätsklinikum Tübingen, Department of Radiation Therapy and Radiation Oncology Recruiting
Tübingen, Germany, 72016
Contact: Daniel Zips, Prof.    +49 7071/29-8 21 65      
Principal Investigator: Daniel Zips, Prof.         
Poland
Uniwersyteckie Centrum Kliniczne, Department of Radiation Therapy and Radiation Oncology Not yet recruiting
Gdańsk, Poland, 80-952
Contact: Rafał Dziadziuszko, Prof.    +48 58 349 2271      
Principal Investigator: Rafał Dziadziuszko, Prof.         
SPZOZ MSW; Warmia & Mazury Oncology Center; Warmia & Mazury Medical University Recruiting
Olsztyn, Poland, 10-228
Contact: Lucyna Kępka, Dr.       lucynak@coi.waw.pl   
Principal Investigator: Lucyna Kępka, Dr.         
Great Poland Cancer Center, Department of Radiotherapy Not yet recruiting
Poznań, Poland, 61-866
Contact: Piotr Milecki, Prof.       piotr.milecki@wco.pl   
Principal Investigator: Piotr Milecki, Prof.         
Sponsors and Collaborators
Technische Universität Dresden
German Consortium for Translational Cancer Research
National Center for Radiation Research in Oncology Dresden/Heidelberg
Radiation Oncology Working Group of the German Cancer Society
Investigators
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Principal Investigator: Rebecca Bütof, Dr. Dresden University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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: February 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dr. Rebecca Bütof, Technische Universität Dresden:
non-small cell lung cancer
radiotherapy
accelerated fractionation
conventional fractionation
postoperative
Additional relevant MeSH terms:
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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