Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003940

Trial Description

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Title

A Randomized Multicenter Study to Compare the Efficacy of Additional Tumor Debulking Surgery vs Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer

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Trial Acronym

DESKTOP III

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URL of the Trial

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Brief Summary in Lay Language

It is still not clear whether a positive AGO-score just selects patients with less
aggressive biologic tumor behavior who as well would have had a positive outcome by
chemotherapy only, or , if it is a score selecting patients who really benefit from surgery.
Nevertheless, the AGO-score was confirmed to select patients with a less than 30% risk of
ending with residual tumor after surgery for recurrent disease. This could avoid including
patients into the present surgical protocol who could not benefit from an operationThe goal
of this third DESKTOP study is to evaluate in a prospectively randomized multicentre
setting, whether maximum effort of cytoreductive surgery followed by platinum based
combination chemotherapy can improve overall survival as compared to platinum based
combination chemotherapy alone in AGO-score positive patients.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00003940
  •   2012/11/30
  •   2010/07/16
  •   yes
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Secondary IDs

  •   NCT01166737  (ClinicalTrials.gov)
  •   AGO-OVAR OP.4 DESKTOP III  (AGO Study Group)
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Health Condition or Problem studied

  •   Fallopian Tube Cancer
  •   Ovarian Cancer
  •   Peritoneal Cavity Cancer
  •   C56 -  Malignant neoplasm of ovary
  •   C78.6 -  Secondary malignant neoplasm of retroperitoneum and peritoneum
  •   C57.0 -  Malignant neoplasm: Fallopian tube
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Interventions/Observational Groups

  •   Procedure: Tumor Debulking Surgery (surgery in recurrent ovarian disease)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
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  •   Parallel
  •   III
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Primary Outcome

- Overall survival in patients with platinum-sensitive recurrent ovarian cancer with a positive AGO-score; time frame: Approximately 36 months after last patient randomized and observation of 244 events

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Secondary Outcome

- Quality of Life; time frame: Baseline, 6, and 12 months after randomization; EORTC QLQ 30 and FACT NCCN Ovarian Symptom Index
- Progression free survival; time frame: Progression free survival is defined as interval between date of randomization and 2nd relapse/progression or death (whatever occurs first).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2010/07/31
  •   408
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Inclusion criteria:

- Patients with first recurrence of platinum sensitive, invasive epithelial ovarian-,
fallopian tube- or primary peritoneal cancer of any initial stage.

- Progression-free interval of at least 6 months after end of last platinum-containing
therapy, or recurrence within 6 months or later after primary surgery if the patient
has not received prior chemotherapy in patients with FIGO I. Non cytostatic
maintenance therapy not containing platinum will not be considered for this
calculation.

- A positive AGO-score. Obligatory requirements for a positive AGO recurrence score in
platinum-sensitive disease:

1. Performance status ECOG 0

2. No residual tumor after primary surgery (if unknown, alternatively primary FIGO
stage I/II). If report from 1st surgery is not available contact study chairman
who will decide whether inclusion is possible or not.

3. Absence of ascites (cut off < 500 ml: radiological or ultrasound estimation)

- Complete resection of the tumor by median laparotomy seems possible

- Patients who have given their signed and written informed consent and their consent
to data transmission and -processing.

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Exclusion Criteria

Exclusion Criteria:

- Patients with non-epithelial tumors as well as borderline tumors.

- Patients without recurrence who are scheduled for diagnostic/second-look surgery or
debulking surgery after completion of chemotherapy

- More than one prior chemotherapy

- Patients with second, third, or later recurrence

- Patients with second malignancies who have been treated by laparotomy, as well as
other neoplasms, if the treatment might interfere with the treatment of relapsed
ovarian cancer or if major impact on prognosis is expected.

- Patients with so-called platinum-refractory tumor, i.e. progression during
chemotherapy or recurrence within 6 months after end of former first
platinum-containing therapy

- Only palliative surgery planned

- Radiological signs suggesting metastases not accessible to surgical removal (i.e.
complete resection is deemed impossible)

- Any concomitant disease not allowing surgery and/or chemotherapy

- Any medical history indicating excessive peri-operative risk

- Any current medication inducing considerable surgical risk (e.g. bleeding: due to
oral anticoagulating agents, bevacizumab)

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Addresses

  • start of 1:1-Block address primary-sponsor
    • AGO Study Group
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    • ARCAGY/ GINECO GROUP
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    • MITO
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    • Arbeitsgemeinschaft Gynaekologische Onkologie Austria
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    • GlaxoSmithKline
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    • medac GmbH
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    • Philipp Harter, MD 
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    • Philipp Harter, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   7
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.