Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Role of Surgery in Advanced Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03980028
Recruitment Status : Completed
First Posted : June 10, 2019
Last Update Posted : June 10, 2019
Sponsor:
Collaborators:
Institut Bergonié
Institut Paoli-Calmettes
Institut du Cancer de Montpellier - Val d'Aurelle
Hospital Universitario La Paz
Hospital Vall d'Hebron
Information provided by (Responsible Party):
Institut Claudius Regaud

Brief Summary:
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.

Condition or disease
Ovarian Cancer

Detailed Description:

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:

  1. 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.
  2. 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.
  3. 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.
  4. 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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 550 participants
Observational Model: Ecologic or Community
Time Perspective: Retrospective
Official Title: Role of Surgery in Advanced Ovarian Cancer
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : January 1, 2019
Actual Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   ovarian cancer
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients diagnosed with advanced epithelial ovarian cancer (IIIC-IVB of FIGO 2014) treated with cytoreduction surgery between 2008, January and 2015, December
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03980028


Locations
Layout table for location information
France
Institut Claudius Regaud - IUCT-Oncopole
Toulouse, Occitanie, France, 31059
Sponsors and Collaborators
Institut Claudius Regaud
Institut Bergonié
Institut Paoli-Calmettes
Institut du Cancer de Montpellier - Val d'Aurelle
Hospital Universitario La Paz
Hospital Vall d'Hebron
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
All the information is provided on this web page in accordance with the RGPD regulations

Publications of Results:

Layout table for additonal information
Responsible Party: Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT03980028    
Other Study ID Numbers: 18 HLGENF 01
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: June 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Claudius Regaud:
surgery
cancer
ovarian
advanced
Additional relevant MeSH terms:
Layout table for MeSH terms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type