Trial document




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  DRKS00019011

Trial Description

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Title

Prospective determination of perioperative Risk of pancreatioduodenectomy after neoadjuvant stereotactic radiotherapy of pancreatic cancer

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Trial Acronym

NeoRad

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Local recurrence of pancreatic cancer is common. One possibility to prevent local recurrence could be preoperative radiotherapy. The aim of the trial is to evaluate the risk for perioperative conplications induced by neoadjuvant radiotherapy shortly before surgical resection.

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Brief Summary in Scientific Language

PDAC is increasingly treated by multimodal regimens including neoadjuvant cancer therapy. Despite limited evidence is neoadjuvant chemotherapy frequently applied in other countries but neoadjuvant trials in Germany have difficulties only recuiting patients. One of the reaseons is the fact that neoadjuvant therapy is usually applied over several months. Patiets are often concerned that if they do not respond to neoadjuvant therapy, the tumor may grow and become unresectable.
With our trial we want to evaluate the perioperative risk of neoadjuvant short term stereotactic radiotherapy applied over 5 days and finishing only 3 days prior to pancreatic surgery. Endpoints are perioperative complications and mortality.
If this strategy proves safe as it has with other cancer types, subsequent trails may examine the oncologic effects if patients recieve neoadjuvant radiotherapy applied during the 3-4 weeks waiting for surgery.

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

Yes

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Description IPD sharing plan:

Data (e.g. radiation protocols etc.) will be shared when no violation of data protection rules is evident

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Organizational Data

  •   DRKS00019011
  •   2019/12/03
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  •   yes
  •   Approved
  •   86/16, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1169-2989 
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Health Condition or Problem studied

  •   C25.0 -  Malignant neoplasm: Head of pancreas
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Interventions/Observational Groups

  •   5 fractions of radiotherapy 3-5 days prior to pancreas resection.
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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)
  •   N/A
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Primary Outcome

Rate of severe complications within 6 weeks after radiotherapy and surgery

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Secondary Outcome

30 day mortality

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2020/01/01
  •   22
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

Patients with histologically proven resectable ductal adenocarcinoma and ability to give written informed consent

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Exclusion Criteria

Participation in trial interfering with the trial
Infiltration of stomach or intestine
Pregnancy and breast feeding
Risk of incompliance
Unwillingness or inability to perform birth control
Bilirubin > 2.5 x upper reference value
Clinically relevant duodenal stenosis
renal insufficiency with GRF<30



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Addresses

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    • Universitätsklinikum Freiburg, Departemnt Chirurgie, Klinik für Allgemein- und Viszeralchirurgie
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Universtitäsklinikum Freiburg Department Chirurgie Klnik für Allgemein- und Viszeralchirurgie
    • Mr.  Prof Dr. med.  Uwe  Wittel 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum FreiburgKlinik für Strahlenheilkunde
    • Ms.  PD Dr.  Eleni  Gkika 
    • Robert-Koch-Straße 3
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg, Departemnt Chirurgie, Klinik für Allgemein- und Viszeralchirurgie
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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