Trial document





This trial has been registered retrospectively.
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  DRKS00006294

Trial Description

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Title

Genetic alterations during treatment of oligometastatic colorectal cancer (GATTACA)

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Trial Acronym

GATTACA

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Aim of this pilot study is to assess the influence of local tumor irradication on the evolution of genetic alterations of circulating tumor DNA in metastatic colorectal carcinoma undergoing systemic chemotherapy plus targeted therapy.

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Brief Summary in Scientific Language

Assesment of the Influences on the evolution of genetic alterations of circulating tumor DNA in patients with metastasized CRC undergoing chemotherapie and local tumor irradication.

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Organizational Data

  •   DRKS00006294
  •   2017/01/12
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  •   yes
  •   Approved
  •   95/14, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
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Secondary IDs

  •   RAD254  (internes Register)
  •   LMU-RAD00001  (interne LMU Studien-ID)
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Health Condition or Problem studied

  •   C20 -  Malignant neoplasm of rectum
  •   C19 -  Malignant neoplasm of rectosigmoid junction
  •   C18 -  Malignant neoplasm of colon
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Interventions/Observational Groups

  •   Patients treated in this study receive a local Therapy (Thermal ablation, Brachytherapy, Mikrowaveablation, stereotactical radiation, surgical resection) after there has been a progress while undergoing Chemotherapy.
    The study will only accompany the intended Treatment, but not influence the chosen methods.
    During the study additional blood samples will be taken during routine blood draws to examinate whether changes in free floating DNA will occur after local Therapy.
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Characteristics

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

There is a proportionality between the fall of the free-circulating tumor DNA 8 weeks after therapy and 16-72 week interval and the progression free survival and / or overall survival. (Check of the degree of response)

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Secondary Outcome

Is tumor recurrence (Progression free survival) associated with a different profile of genetic alterations?

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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
  •   2016/03/02
  •   36
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

1. histologically proven oligometastatic colorectal cancer
(Oligometastatic disease status defined as involving up to 3 organ systems; up to 3 metastases per organ system)
2. Any treatment line irrespective of previous chemotherapy lines
3.Patient treatment recommendation confirmed by an institutional multidisciplinary tumor board (MDT)
4.Metastases amenable to complete ablation/resection using different techniques (radiofrequency ablation, thermoablation, photon beam radiation, surgery, including minimal invasive resections)
5.Age >18 Jahre
6.Life expectancy > 12 months
7. signed and dated consent form

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Exclusion Criteria

1. Patients with metastases involving more than 3 organ systems (e.g. liver, lung, bone and retroperitoneal compartment)
2. Patients with peritoneal or pleural metastases
3. Patient having undergone Whipple Operation
4. Second carcinoma, except carcinoma in situ of the cervix or basal cell carcinoma.
5. Pregnancy

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Addresses

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    • Universitätsklinikum Magdeburg
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Klinik für Radiologie und NuklearmedizinUniversität Magdeburg
    • Mr.  Prof.  Jens  Ricke 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Klinik für Radiologie und Nuklearmedizin
    • Ms.  Christel  Besseler 
    • Leipziger Strasse 44
    • 39120  Magdeburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Magdeburg
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Klinik und Poliklinik für Radiologie Klinikum der Universität München Campus Großhadern
    • Mr.  Prof.  Jens  Ricke 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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    •   (089) 4400-4400 72750
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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