Trial document





This trial has been registered retrospectively.
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  DRKS00003658

Trial Description

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Title

Stereotactic fraktionated radiotherapy in patients with medically inoperable small lung tumors (STRIPE I): a phase II study

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Trial Acronym

STRIPE I

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URL of the Trial

[---]*

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Brief Summary in Lay Language

stereotactic fractioneated radiotherapy in patients with not more than 2 small lung tumors (NSCLC or metastases of other primaries), who are medically inoperable by interdisciplinary consensus

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Brief Summary in Scientific Language

phase II study to evaluate the local control after stereotactic fractionated radiotherapy in patients with medically inoperable small lung tumors

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Organizational Data

  •   DRKS00003658
  •   2012/04/18
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  •   yes
  •   Approved
  •   366/08, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   C34 -  Malignant neoplasm of bronchus and lung
  •   C78.0 -  Secondary malignant neoplasm of lung
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Interventions/Observational Groups

  •   stereotactic fractionated radiotherapy of small lung tumors in 3 to 5 fractions
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
  •   N/A
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Primary Outcome

local tumor control after two years of follow-up

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Secondary Outcome

- actuarial local progression free surviva
- overall survival over two years of follow-up
- standardized QoL (EORTC QLQ C30 and LC13)
- individual QoL (SEIQoL-DW Score)
- Toxicity of SR in small lung tumors (CTC score)
- Feasibility of integrated cone beam CT for patient positioning in SR
- Impact of respiratory gated FDG-PET/CT in SR planning and follow up
- Detection of tumor progression by CT vs. FDG-PET

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2011/02/15
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

- presence of one or two FDG-PET positive pulmonary nodules </= 5cm diameter suspicious for primary lung cancer or metastasis by CT
- Karnofsky index >/= 60%
- Life expectancy > 6 months
- Age > 18 years (no other age limits)
- Informed consent signed in accordance with institutional protocol

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Exclusion Criteria

- NSCLC: FDG-PET N+ if not ruled out by mediastinoscopy or other tissue sampling
- in metastases: disseminated progressive disease without local control to be reasonably expected by current treatment
- Histologically proven SCLC
- More than two lesions to treat
- Diameter of tumor > 5cm
- Systemic therapy +/- one week of treatment
- psychological/mental status does not allow informed consent and participation in QoL assessments
- Pregnancy

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Addresses

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    • Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
    • Ms.  Prof.  Ursula  Nestle 
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
    • Ms.  Prof.  Ursula  Nestle 
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Krebshilfe e.V.
    • Buschstr. 32
    • 53113  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/11/26
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Trial Publications, Results and other Documents

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