Trial document




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  DRKS00010785

Trial Description

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Title

Trial on radical upfront surgery in advanced ovarian cancer in Germany extended part for fragility and long term quality of life

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Trial Acronym

AGO-OVAR 19

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

First part: Fragile Study
There is clear evidence that there is a subgroup of vulnerable patients with ovarian cancer who do not benefit from standard strategies or are even harmed by this approach. This might be characterized by rapid deterioration of health and functional decline. Fragility is caused by multiple factors such as comorbidities, tumor burden and with older age. This status of health is of special interest in ovarian cancer due to several reasons: the median age of ovarian cancer is 69 years and elderly patients are the fastest growing population among ovarian cancer patients and have the highest incidence of comorbidities.
The identification of vulnerable and fragile ovarian cancer patients is an unmet medical need. This study prospectively evaluates functional, constitutional, laboratory and disease-related factors to identify a fragile subgroup of patients who do not benefit from standard therapeutic strategies.
Second Part: Quality of life Study
As of today, only marginal differences in quality of life were reported between the treatment arms. Unfortunately, quality of life was mainly measured during treatment or follow up until progression. So far, data regarding long term quality of life (QoL) are missing, because until now the trials stopped to evaluate QoL at the time point of progression. Influence of progression including subsequent treatment was not investigated. Therefore, differences regarding efficacy in progression-free-survival only might underestimate the treatment effect if quality of post progression survival is neglected. Consequently, longitudinal evaluation of quality of life is urgently needed for better understanding of “progression free survival-only” results of prospective trials.

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Organizational Data

  •   DRKS00010785
  •   2016/07/05
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  •   yes
  •   Approved
  •   22-16, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

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Health Condition or Problem studied

  •   C56 -  Malignant neoplasm of ovary
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Interventions/Observational Groups

  •   First part – Fragile Study:
    There are no specific study related interventions. Surgery and/or Systemic therapy are up to investigators discretion according to national German guidelines and standard of care.
    Clinical exams and fragility assessment at baseline.
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    Second part - Quality of Life Study:
    There are no specific study related interventions. QoL questionnaires will be done for up to 36 months.

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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

First part Fragile Study:
Primary endpoint:
Evaluation of factors to describe the cohort of patients who may not benefit from surgery and chemotherapy (≠ cure or at least platinum sensitive relapse, defined as no progression within 10 months after registration/randomization) as defined in section sample size calculation/statistical analysis (candidates for predictors).

Second part Quality of Life Study:
Primary endpoint:
Long term Quality of Life (QoL) assessed by EORTC QLQ-C30 and QLQ-OV28 (including functional and symptom scales) to describe the influence of treatment and course of disease on quality of life.

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/08/16
  •   440
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

First and second part of the study:
• Suspected invasive or histologically confirmed, primary epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma. Cytological diagnosis and/or biopsy before study participation are allowed.
• Signed written informed consent obtained prior to registration.
• Females aged ≥ 18 years
• Suspected FIGO stage IIB - IVB (all grades and all histological types)

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Exclusion Criteria

First and second part of the study:
• Malignancy of non-epithelial origin of the ovary, the fallopian tube or the peritoneum.
• Borderline tumours (tumours of low malignant potential) and FIGO stage IA – IIA tumours
• Recurrent ovarian cancer.
• Definitive cytoreductive surgery prior to signed informed consent.
• Prior systemic antineoplastic therapy for ovarian cancer (for example chemotherapy, monoclonal antibody therapy, tyrosine-kinase-inhibitor therapy and/or hormonal therapy).
• Dementia or significantly altered mental status, that would prohibit the understanding and giving of informed consent
• Pregnancy
• Any reasons interfering with regular follow-up.

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Addresses

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    • AGO Research GmbH / AGO-Study Group
    • Kaiser-Friedrich-Ring 71
    • 65185  Wiesbaden
    • Germany
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    • Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Klinikum der Universität München
    • Mr.  Prof. Dr. med.  Sven  Mahner 
    • Marchioninistrasse 15
    • 81377  München
    • Germany
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    • AGO Research GmbH / AGO -Study Group
    • Ms.  Gabriele  Elser 
    • Kaiser-Friedrich-Ring 71
    • 65185  Wiesbaden
    • Germany
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Sources of Monetary or Material Support

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    • AGO Research GmbH / AGO-Study Group
    • Kaiser-Friedrich-Ring 71
    • 65185  Wiesbaden
    • Germany
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    • ROCHE Pharma AG
    • Emil-Barell-Str. 1
    • 79639  Grenzach-Wyhlen
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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