Trial document




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  DRKS00020290

Trial Description

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Title

RADprecise - Personalized radiotherapy: incorporating cellular response to irradiation in personalized treatment planning to minimize radiation toxicity

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Trial Acronym

RADprecise

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URL of the Trial

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Brief Summary in Lay Language

The RADprecise collaborative project aims to personalize radiotherapy treatment for cancer patients. We plan to improve the prediction of the risk for side effects after radiotherapy using multiple biomarkers in addition to clinical and personal factors. Information from the prediction models shall be incorporated into radiotherapy treatment planning systems.

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Brief Summary in Scientific Language

The aim of this collaborative translational project is to personalize radiotherapy (RT) treatment for cancer patients by incorporating information from improved predictive models for RT-induced
toxicity based on data from multiple biomarkers of individual radiosensitivity into treatment planning systems.

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

If patients gave their consent, pseudonymized data can be shared with external Researchers after the end of the project. This requires a scientifically Sound concept form to be submitted to the coordinator and, after approval, a data transfer agreement to be signed.

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Organizational Data

  •   DRKS00020290
  •   2020/01/03
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  •   yes
  •   Approved
  •   S-583/2019, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   C50 -  Malignant neoplasm of breast
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   - Breast and prostate cancer patients who received radiotherapy are followed up annually for radiotherapy related side effects and complete a questionnaire on quality of life/patient reported outcomes.
    - Biomarkerassays
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

- Breast: Breast toxicities after a minimum of 3 years after radiotherapy

- Prostate gastro-intestinal (GI): Gastrointestinal toxicity after a minimum of 3 years after radiotherapy

- Prostate genito-urinary (GU): Urinary toxicity after a minimum of 3 years after radiotherapy

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Secondary Outcome

- Other toxicity endpoints including but not limited to: cosmesis, vascular changes, pain (breast); erectile dysfunction (prostate)
- Patient reported outcomes
- Quality of life, fatigue

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Countries of Recruitment

  •   Germany
  •   Italy
  •   Spain
  •   United Kingdom
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Doctor's Practice 
  • Doctor's Practice 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
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Recruitment

  •   Planned
  •   2020/01/06
  •   1050
  •   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

- Adult breast or prostate cancer patients who received radiotherapy and have participated in the REQUITE study in Germany, Italy, Spain, UK and who are alive at re-contact
- Willingness and ability to comply with at least one scheduled visit
- The capacity to understand the patient information sheet and the ability to provide written informed consent

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Exclusion Criteria

- Re-irradiation of the region of initial radiotherapy (including contralateral breast)
- Any breast surgery after initial RT, mastectomy patients (including contralateral breast)
- Mental disability or patient otherwise unable to give informed consent and/or complete patient questionnaires
- Known HIV infection, hepatitis B or hepatitis C not eligible for sample collection

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Addresses

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    • Deutsches Krebsforschungszentrum (DKFZ) / German Cancer Research Center
    • 69120  Heidelberg
    • Germany
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    • Deutsches Krebsforschungszentrum
    • Ms.  Prof.  Jenny  Chang-Claude 
    • Im Neuenheimer Feld 581
    • 69120  Heidelberg
    • Germany
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    • Deutsches Krebsforschungszentrum (DKFZ)
    • Ms.  Prof.  Jenny  Chang-Claude 
    • Im Neuenheimer Feld 581
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung
    • 10115  Berlin
    • Germany
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    • ANR - Agence Nationale de la Recherche
    • 75012  Paris
    • France
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    • FRRB - Fondazione Regionale per la Ricerca Biomedica - Regional Foundation for Biomedical Research
    • 20124  Milan
    • Italy
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    • ISCIII - National Institute of Health Carlos III
    • 28029  Madrid
    • Spain
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    • DS-CAT - Health Department – Generalitat de Catalunya
    • 08028  Barcelona
    • Spain
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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