Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007804

Trial Description

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Title

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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

In this randomized multicentric phase II study it will be investigated whether an
accelerated postoperative radiotherapy (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).

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Brief Summary in Scientific Language

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 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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Organizational Data

  •   DRKS00007804
  •   2016/02/19
  •   2014/05/22
  •   yes
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Secondary IDs

  •   NCT02189967  (ClinicalTrials.gov)
  •   STR-PORTAF-2014  (Technische Universität Dresden)
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Health Condition or Problem studied

  •   Non-Small Cell Lung Cancer
  •   C34 -  Malignant neoplasm of bronchus and lung
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Interventions/Observational Groups

  •   Radiation: conventional fractionation
  •   Radiation: accelerated fraction
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   II
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Primary Outcome

- 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).

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Secondary Outcome

- 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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Countries of Recruitment

  •   Germany
  •   Poland
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Locations of Recruitment

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Recruitment

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  •   2014/08/31
  •   308
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- histologically confirmed non-small cell lung cancer

- previous tumor resection with curative intention

- postoperative indication for irradiation (> pN1 and/ or R1)

- 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

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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)

- 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

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Addresses

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    • Technische Universität Dresden
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    • German Consortium for Translational Cancer Research
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    • National Center for Radiation Research in Oncology Dresden/Heidelberg
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    • Radiation Oncology Working Group of the German Cancer Society
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    • Dresden University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology
    • Michael Baumann, Prof. Dr. 
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    • Michael Baumann, Prof. Dr. 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2015/05/04
* This entry means the parameter is not applicable or has not been set.