Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006512

Trial Description

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Title

Hypofractionated Ion Irradiation (Carbon Ions Versus Protons) of the Prostate

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Trial Acronym

IPI

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The purpose of this study is to evaluate the safety and feasibility of primary
hypofractionated irradiation of the prostate with carbon ions or protons using the raster
scan technique.

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Brief Summary in Scientific Language

as published: Habl G, Hatiboglu G, Edler L, Uhl M, Krause S, Roethke M, Schlemmer HP,
Hadaschik B, Debus J, Herfarth K: Ion Prostate Irradiation (IPI) - a pilot study to
establish the safety and feasibility of primary hypofractionated irradiation of the prostate
with protons and carbon ions in a raster scan technique. BMC cancer 2014, 14(1):202.

http://www.ncbi.nlm.nih.gov/pubmed/24641841

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Organizational Data

  •   DRKS00006512
  •   2015/04/14
  •   2012/07/06
  •   yes
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Secondary IDs

  •   NCT01641185  (ClinicalTrials.gov)
  •   IPI  (Heidelberg University)
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Health Condition or Problem studied

  •   Prostatic Neoplasms
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Procedure: radiation
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Treatment
  •   Parallel
  •   II
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Primary Outcome

- proctitis and cystitis; time frame: 3 years; via incidence grade 3-4 toxicity (NCI-CTC-AE)

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Secondary Outcome

- PSA-PFS; time frame: 3 years; by measuring PSA values every 3 months
- OS; time frame: 3 years
- quality of life; time frame: 3 years; by questionnaire

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

  •   [---]*
  •   2012/05/31
  •   92
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Inclusion Criteria

  •   Male
  •   40   Years
  •   80   Years
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Additional Inclusion Criteria

histological proven carcinoma of the prostate with Gleason score risk of lymphe node
involvement of <15% calculated by the Yale-formula; Risk [%] = [GS -5] x [PSA/3 + 1.5 x
T], mit T = 0, 1, and 2 for cT1c, cT2a, und cT2b/cT2c

- Karnofsky-Index ≥ 70%

- age between 40 and 80 years

- PSA

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Exclusion Criteria

Stadium IV (distant metastases) Lymphogenous Metastases hip replacement former irradiation
of the pelvis pacemaker defibrillator

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Heidelberg University
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    • University Hospital of Heidelberg
    • Klaus Herfarth, Prof. Dr. 
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    • University Hospital of Heidelberg
    • Klaus Herfarth, Prof. Dr. 
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2015/12/01
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Trial Publications, Results and other Documents

  •   Habl G, Hatiboglu G, Edler L, Uhl M, Krause S, Roethke M, Schlemmer HP, Hadaschik B, Debus J, Herfarth K. Ion Prostate Irradiation (IPI) - a pilot study to establish the safety and feasibility of primary hypofractionated irradiation of the prostate with protons and carbon ions in a raster scan technique. BMC Cancer. 2014 Mar 19;14:202. doi: 10.1186/1471-2407-14-202.; 24641841
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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 .
  •   3
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.