Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003647

Trial Description

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Title

Randomized, Multicentre Trial for Lymphadenectomy In Ovarian Neoplasms

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Trial Acronym

LION

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URL of the Trial

[---]*

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Brief Summary in Lay Language

To assess the efficacy of systematic pelvic and para-aortic lymphadenectomy in patients with
advanced ovarian cancer and intra-abdominal complete debulking.

Secondary: progression-free survival, complications and quality of life; Exploratory: Role
of number of resected lymph nodes for primary and secondary objectives

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Brief Summary in Scientific Language

[---]*

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Organizational Data

  •   DRKS00003647
  •   2012/05/04
  •   2008/07/03
  •   yes
  •   [---]*
  •   [---]*
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Secondary IDs

  •   NCT00712218  (ClinicalTrials.gov)
  •   AGO-OVAR OP.3  (Carmen Schade-Brittinger)
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Health Condition or Problem studied

  •   Ovarian Cancer
  •   C50 -  Malignant neoplasm of breast
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Interventions/Observational Groups

  •   Procedure: No Lymphadenectomy (LNE)
  •   Procedure: Lymphadenectomy (LNE)
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
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Primary Outcome

- Overall Survival; time frame: time from randomization until death

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Secondary Outcome

- - Progression-free survival (PFS) - Quality of life (QoL) as measured by EORTC QLQ-C30, OV28 - number of resected lymph nodes; time frame: Progression-free survival time is calculated from the date of surgery until the date of first progressive disease or death, whichever occurs first or date of last contact (censored observation).

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Countries of Recruitment

  •   Austria
  •   Belgium
  •   Czech Republic
  •   Germany
  •   Italy
  •   Korea, Republic of
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Locations of Recruitment

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Recruitment

  •   [---]*
  •   2008/12/31
  •   640
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Female
  •   18   Years
  •   75   Years
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Additional Inclusion Criteria

- Primary diagnosis of invasive epithelial ovarian cancer FIGO stage IIB-IV (IV only if
resectable metastasis in pleura, liver, spleen, and/or abdominal wall)

- Macroscopic complete resection

- Age: 18 - 75 years

- Patients who have given their signed and written informed consent

- Good performance status (ECOG 0/1)

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Exclusion Criteria

- Non epithelial ovarian malignancies and borderline tumors

- Intraoperative clinically suspicious lymph nodes (bulky nodes)

- Secondary invasive neoplasms in the last 5 years (except synchronal endometrial
carcinoma FIGO IA G1/2, non melanoma skin cancer, breast cancer T1 N0 M0 G1/2) or
with any signs of relapse or activity.

- Recurrent ovarian cancer

- Prior chemotherapy for ovarian cancer or abdominal/pelvic radiotherapy

- Diseases of the lymph system (including lymph edema of unknown origin)

- Clinical relevant dysfunctions of blood clotting (including medicamentous conditioned
reasons, e.g. ASS, if not stopped at least 7 days prior to surgery)

- Any significant medical reasons, age or performance status that will not allow to
perform the study procedures (estimation of investigator)

- Prior retroperitoneal lymph node dissection (systematic or sampling)

- Pregnancy

- Dementia or significantly altered mental status that would prohibit the understanding
and giving of informed consent

- Any reasons interfering with regular follow-up

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Carmen Schade-Brittinger
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    •   [---]*
    •   [---]*
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    • University Marburg
    • Uwe Wagner, MD, Prof 
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    • University Marburg
    • Uwe Wagner, MD, Prof 
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    •   [---]*
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
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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 .
  •   4
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.