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OpenTrials
Completed

NCT Number: NCT03980028

Role of Surgery in Advanced Ovarian Cancer

To demonstrate that ultra-radical surgery with multiple visceral resections and high tumor burden prior to surgery independently reduces the survival of patients with advanced ovarian cancer treated with complete cytoreductive surgery.

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Key information

About this study

Primary objective :

To demonstrate that ultra-radical surgery with multiple visceral resections and high tumor burden prior to surgery independently reduces the survival of patients with advanced ovarian cancer treated with complete cytoreductive surgery.

Secondary objectives:

  • Demonstrate that, in patients with advanced ovarian cancer (FIGO stage IIIC-IVB) treated by complete cytoreduction surgery, the high tumor load before surgery decreases survival. / Evaluate whether there is a sub-group of patients at risk for whom the high tumor burden prior to surgery reduces survival.
  • Demonstrate that, in patients with advanced ovarian cancer (FIGO stage IIIC-IVB) treated by complete cytoreduction surgery, the extension of carcinomatosis to the upper abdomen reduces the chances of survival. / Assess whether there is a subgroup of patients at risk for whom the extension of carcinomatosis to the upper abdomen reduces survival.
  • Demonstrate that, in patients with advanced ovarian cancer (FIGO Stage IIIC-IVB) treated by complete cytoreduction surgery, invasion of the celiac lymph nodes reduces survival rates. / Assess whether there is a subset of patients at risk where the invasion of the celiac lymph nodes reduces survival.
  • Demonstrate that, in patients with advanced ovarian cancer (FIGO stage IIIC-IVB) treated with complete cytoreduction surgery, combination with surgical procedures reduces survival. / Evaluate whether there is a sub-group of at-risk patients for whom the combination of surgical procedures with ultra-radical surgery reduces survival.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • confirmed histological diagnosis of ovarian epithelial cancer
  • complete cytoreduction surgery

Exclusion criteria

  • women under 18 years or presence of residual tumor >2.5mm after surgery or lack of data on performed surgical procedures or surgery performed before 2008, January or after 2015, Decembrer.

Treatment and study plan

Primary outcomes

  1. Patient survival

    Time frame: 4 years

    patient survival after surgery (patient record)

  2. Evaluation of the tumor burden

    Time frame: 1 day

    Measurement of tumor size before surgery (patient record)

Secondary outcomes

  1. Evaluation of the extension of carcinomatosis

    Time frame: 1 day

    Number of tumor nodules before surgery (patient record)

  2. Evaluation of the invasion of celiac lymph nodes

    Time frame: 1 day

    Number of celiac lymph nodes before surgery (patient record)

  3. Combination of surgical procedures

    Time frame: 1 day

    Number and type of combination of surgical procedures (patient record)

Sponsors and collaborators

Lead sponsor

Institut Claudius Regaud

Other

Collaborators

  • Hospital Universitario La Paz
  • Hospital Vall d'Hebron
  • Institut Bergonié
  • Institut Paoli-Calmettes
  • Institut du Cancer de Montpellier - Val d'Aurelle

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 10, 2019
Registry last updated
Jun 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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