Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00011856

Trial Description

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Title

Interdisciplinary patient-centred care with quality control within palliative therapy of colorectal carcinoma (IVOPAK II)
A Treatment path based on the Guidelines
- Personalized therapy of colorectal cancer (CRC) with region-wide controll supply -

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Trial Acronym

IVOPAK II

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Primary Goal of the study is obtaining the best treatment for all study participants by achieving secondary mestastatic resection after downsizing of palliative therapy by close interdisciplinary collaboration of practice-based oncologists and participating hospitals with University Hospital Erlangen and the interdisciplinary tumour-board of the Surgery of University Hospital Erlangen.

The evaluation of the Prior study "IVOPAK I" showed that there were considerable differences between the participating centres with regard to overall survival and frequency of secondary metastatic resection. Furthermore it proved that not all participating centres were connected with an interdisciplinary tumour-board.

Goal of the "IVOPAK II" study is achieving healing respectively good overall survival time by working close together and by applying guideline-based therapies.

The study is eligible for patients aged between 18 and 75 years who have a metastatic colorectal carcinoma.

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Brief Summary in Scientific Language

Prognostic optimizing of the study participants by connecting all patients with the interdisciplinary tumour-board of University Hospital Erlangen which is especially experienced within surgical oncology within the meaning of achieving a secondary metastatic resection after Downsizing of palliative therapy.

Goal of the study is achieving an improvement of quality results and reaching a curative Option for most of the patients by close interdisciplinary collaboration and by offering guideline-based palliative therapies.

One endpoint is Assimilation of the quality results within the participating centres and enclosed patients by close Connection with an interdisciplinary tumour-centre which is especially experienced within surgical oncology.

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Organizational Data

  •   DRKS00011856
  •   2017/04/21
  •   [---]*
  •   yes
  •   Approved
  •   67_16B, Ethik-Kommission der Friedrich-Alexander-Universität Erlangen-Nürnberg
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Secondary IDs

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

  •   Metastatic Colorectal Cancer
  •   C18 -  Malignant neoplasm of colon
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Interventions/Observational Groups

  •   We test if the patients have an all-RAS wild-type or a mutation. On the basis of the pathological molecular biological determination we find out if there exists a K-RAS and N-RAS (All-RAS)-wildtype or a mutation of the patient's tumour. If all-RAS-wildtype is determined, an anti-EGFR-therapy e. g. with cetuximab plus chemotherapy e. g. FOLFIRI-regimen, according to the current guidelines is initiated. If a mutation is determined, an anti-VEGFR-therapy with bevacizumab plus chemotherapy first-line is initiated.
  •   On the basis of the pathological-molecular biological determination (by a certificated pathological institute) a systemic therapy with a combined chemotherapy with irinotecan (FOLFIRI) or a combined chemotherapy with oxaliplatin (FOLFOX4) plus bevacizumab is initiated if a mutation of K-RAS (exon 2, 3, 4) or N-RAS (exon 2, 3, 4) in the tumour tissue is determined and the imaging clinical monitoring is presented bi-monthly (continous-check-strategy) in the interdisciplinary tumour-board, performing a secondary metastatic resection after downsizing of first- or second-line therapy. The prognosis of the palliative patients should be improved and a curative option should be achieved by interdisciplinary collaboration (conversion).
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Treatment
  •   Other
  •   IV
  •   No
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Primary Outcome

implementation of the interdisciplinary tumour board recommandations

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Secondary Outcome

Overall survival; frequency and success of secondary metastatic resection with detection of morbidity and mortality andlLong-term survival time

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/08/09
  •   250
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

ECOG-index: 0-1: Age > 18 years

existence of all-RAS-Status (certified pahology)

patients with definitively non-resectable
distant metastases of a CRC defined by the
interdisciplinary tumour-board of Surgical
Hospital Erlangen, and presentation there

histological assurance of an adeno-carcinoma
of the colon (> 16 cm from anocutaneous line)
or of the rectum with non-resectable distant
metastases (synchronous or metachronous)

palliative chemonaive patients related to first-
line therapy, adjuvant therapy CT/neoadjuvant
RT-CT before >= 6 months allowed

negative pregnancy test of premenopauseal
women

Patient signed written consent

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Exclusion Criteria

- missing patient written consent

- e.g. contra-indication against cetuximab,
bevacizumab or another therapy Option

- age: < 18 years

- ECOG-index 2: Age > 75 years

- no initial presentation at an interdisciplinary
tumour-board with regard to non-resectability
of the distant metastases

- no adequate contraception for premenopauseal
women

- pregnancy and lactation

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Addresses

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    • Universitätsklinikum Erlangen
    • Mr.  Dr. jur.  Albrecht  Bender 
    • Maximiliansplatz 2
    • 91054  Erlangen
    • Germany
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    • Universitätsklinikum ErlangenChirurgische Klinik
    • Mr.  Prof. Dr. med.  Robert  Grützmann 
    • Krankenhausstr. 12
    • 91054  Erlangen
    • Germany
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    • Universitätsklinikum ErlangenMed 1
    • Mr.  Prof. Dr. med.  Axel  Wein 
    • Ulmenweg 18
    • 91054  Erlangen
    • Germany
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    • Universitätsklinikum Erlangen
    • Mr.  Prof. Dr. med.  Axel  Wein 
    • Ulmenweg 18
    • 91054  Erlangen
    • Germany
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Sources of Monetary or Material Support

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    • medac Gesellschaft für klinische Spezialpräparate mbH
    • Mr.  Markus  Drees 
    • Theaterstr. 6
    • 22880  Wedel
    • 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.