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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02189967
Recruitment Status : Completed
First Posted : July 15, 2014
Last Update Posted : July 22, 2020
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

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.

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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

Resource links provided by the National Library of Medicine


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.




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.



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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

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


Locations
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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
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
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: July 22, 2020
Last Verified: July 2020
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