Trial document




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  DRKS00011886

Trial Description

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Title

Pilot study for the introduction of standardized, pretherapeutic endoscopy, possibly with marker implantation (Visicoil), in patients with esophageal carcinoma eligible for primary therapy with curative intent at UCC Dresden

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Trial Acronym

EVI

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Gastro-oesophageal endoscopy in the context of diagnosis prior to initiation of the routine therapy in patients with oesophageal carcinoma. During this procedure fiducial gold markers will possibly be impantet for demarcation of the tumor. Within the study, the feasibility and safety of the endoscopy will be assessed and recorded.

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Brief Summary in Scientific Language

In this study, a gastro-oesophageal endoscopy with a possible implantation of fiducial gold markers (Visicoil®) will be implemented as part of the pretherapeutic diagnostics of patients with esophageal carcinoma prior to the FDG-PET-CT scan. The aim of this pilot study is to report the technical feasibility and to guarantee the safety of the endoscopic procedure and fiducial marker placement to establish this as standard diagnostics at the UCC Dresden.
During the endoscopic procedure, markers will be inserted directly adjacent to the proximal and distal end of the macroscopically visible primary tumor. In tumors not occupying the full circumference of the esophagus, 1-2 additional markers will be injected in the opposite wall of the esophagus. Through this, valuable information on the tumor expansion (target volume delineation for radiation therapy) and on the therapy decision (primary resection, resection after neoadjuvant radiochemotherapy or primary radiochemotherapy) are collected. The implantation is not performed in case the endoscopic procedure is hamperedy showsby a complete or partial obstruction of the esophagus, which prevents the passage of the tumor with the endoscope.

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Organizational Data

  •   DRKS00011886
  •   2017/05/31
  •   [---]*
  •   yes
  •   Approved
  •   EK148042017, Ethikkommission der Medizinischen Fakultät der Technischen Universität Dresden
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C15.1 -  Malignant neoplasm: Thoracic part of oesophagus
  •   C15.2 -  Malignant neoplasm: Abdominal part of oesophagus
  •   C15.3 -  Malignant neoplasm: Upper third of oesophagus
  •   C15.4 -  Malignant neoplasm: Middle third of oesophagus
  •   C15.5 -  Malignant neoplasm: Lower third of oesophagus
  •   C15.8 -  Malignant neoplasm: Overlapping lesion of oesophagus
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Interventions/Observational Groups

  •   Endoscopy and possibly endoscopy-supported implantation of Fiducial Goldmarkers (Visicoil®) in patients with esophageal carcinoma prior to performing routine FDG PET CT imaging.
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   [---]*
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Primary Outcome

Implementation of endoscopy with possible gold marker implantation as a feasible, safe, pretherapeutic diagnostic method.

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Secondary Outcome

• Toxicity / AE (CTCAE 4.0) after implantation of the “Visicoil” markers
• Number and position of the injected Markers
• Visibility of the markers and their geometrical stability prior to and during treatment on routinely performed FDG-PET/CT imaging and on weekly control-CT in patients undergoing proton irradiation.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/07/27
  •   20
  •   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

• histologically confirmed tumor
• Patients with cT2 N0 M0 tumors that are suitable for primary resection
• Patients with cT2-4 N + M0 tumors suitable for neoadjuvant radiochemotherapy (41.4 Gy) followed by resection
• Patients with cT2-4 N + M0 tumors that are eligible for primary radiochemotherapy due to co-morbidities or patient requirements
• Complete stenosis of the esophagus was excluded
• written patient consent

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Exclusion Criteria

• Presence of distant metastases
• Patients who are not suitable for curative treatment

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Addresses

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    • Universitätsklinikum Dresden, Klinik und Poliklinik für Strahlentherapie und Radioonkologie
    • Ms.  Prof.  Esther  Troost 
    • Fetscherstraße 74
    • 01307  Dresden
    • Germany
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    • Universitätsklinikum Dresden, Klinik und Poliklinik für Strahlentherapie und Radioonkologie
    • Ms.  Prof.  Esther  Troost 
    • Fetscherstraße 74
    • 01307  Dresden
    • Germany
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    • Universitätsklinikum Dresden, Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Klinisches Studienzentrum
    • Ms.  Annett  Klöber 
    • Fetscherstraße 74
    • 01307  Dresden
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Carl Gustav Carus
    • Fetscherstr. 74
    • 01307  Dresden
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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