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出境医 / 临床实验 / Role of Surgery in Advanced Ovarian Cancer

Role of Surgery in Advanced Ovarian Cancer

Study Description
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.
Study Design
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
Arms and Interventions
Outcome Measures
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)


Eligibility Criteria
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.
Contacts and Locations

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
Tracking Information
First Submitted Date June 4, 2019
First Posted Date June 10, 2019
Last Update Posted Date June 10, 2019
Actual Study Start Date January 1, 2018
Actual Primary Completion Date January 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 6, 2019)
  • Patient survival [ Time Frame: 4 years ]
    patient survival after surgery (patient record)
  • Evaluation of the tumor burden [ Time Frame: 1 day ]
    Measurement of tumor size before surgery (patient record)
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 6, 2019)
  • Evaluation of the extension of carcinomatosis [ Time Frame: 1 day ]
    Number of tumor nodules before surgery (patient record)
  • Evaluation of the invasion of celiac lymph nodes [ Time Frame: 1 day ]
    Number of celiac lymph nodes before surgery (patient record)
  • Combination of surgical procedures [ Time Frame: 1 day ]
    Number and type of combination of surgical procedures (patient record)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Role of Surgery in Advanced Ovarian Cancer
Official Title Role of Surgery in Advanced Ovarian Cancer
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.
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.
Study Type Observational
Study Design Observational Model: Ecologic or Community
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Ovarian Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *
  • Bristow RE, Chi DS. Platinum-based neoadjuvant chemotherapy and interval surgical cytoreduction for advanced ovarian cancer: a meta-analysis. Gynecol Oncol. 2006 Dec;103(3):1070-6. Epub 2006 Jul 27.
  • Vergote I, Tropé CG, Amant F, Kristensen GB, Ehlen T, Johnson N, Verheijen RH, van der Burg ME, Lacave AJ, Panici PB, Kenter GG, Casado A, Mendiola C, Coens C, Verleye L, Stuart GC, Pecorelli S, Reed NS; European Organization for Research and Treatment of Cancer-Gynaecological Cancer Group; NCIC Clinical Trials Group. Neoadjuvant chemotherapy or primary surgery in stage IIIC or IV ovarian cancer. N Engl J Med. 2010 Sep 2;363(10):943-53. doi: 10.1056/NEJMoa0908806.
  • du Bois A, Reuss A, Pujade-Lauraine E, Harter P, Ray-Coquard I, Pfisterer J. Role of surgical outcome as prognostic factor in advanced epithelial ovarian cancer: a combined exploratory analysis of 3 prospectively randomized phase 3 multicenter trials: by the Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom (AGO-OVAR) and the Groupe d'Investigateurs Nationaux Pour les Etudes des Cancers de l'Ovaire (GINECO). Cancer. 2009 Mar 15;115(6):1234-44. doi: 10.1002/cncr.24149.
  • Eisenkop SM, Spirtos NM, Friedman RL, Lin WC, Pisani AL, Perticucci S. Relative influences of tumor volume before surgery and the cytoreductive outcome on survival for patients with advanced ovarian cancer: a prospective study. Gynecol Oncol. 2003 Aug;90(2):390-6.
  • Chi DS, Franklin CC, Levine DA, Akselrod F, Sabbatini P, Jarnagin WR, DeMatteo R, Poynor EA, Abu-Rustum NR, Barakat RR. Improved optimal cytoreduction rates for stages IIIC and IV epithelial ovarian, fallopian tube, and primary peritoneal cancer: a change in surgical approach. Gynecol Oncol. 2004 Sep;94(3):650-4.
  • Chi DS, Eisenhauer EL, Zivanovic O, Sonoda Y, Abu-Rustum NR, Levine DA, Guile MW, Bristow RE, Aghajanian C, Barakat RR. Improved progression-free and overall survival in advanced ovarian cancer as a result of a change in surgical paradigm. Gynecol Oncol. 2009 Jul;114(1):26-31. doi: 10.1016/j.ygyno.2009.03.018. Epub 2009 Apr 23.
  • Chi DS, Zivanovic O, Levinson KL, Kolev V, Huh J, Dottino J, Gardner GJ, Leitao MM Jr, Levine DA, Sonoda Y, Abu-Rustum NR, Brown CL, Barakat RR. The incidence of major complications after the performance of extensive upper abdominal surgical procedures during primary cytoreduction of advanced ovarian, tubal, and peritoneal carcinomas. Gynecol Oncol. 2010 Oct;119(1):38-42. doi: 10.1016/j.ygyno.2010.05.031. Epub 2010 Jul 6.
  • Schulman-Green D, Ercolano E, Dowd M, Schwartz P, McCorkle R. Quality of life among women after surgery for ovarian cancer. Palliat Support Care. 2008 Sep;6(3):239-47. doi: 10.1017/S1478951508000497.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 6, 2019) 		550
Original Actual Enrollment Same as current
Actual Study Completion Date June 1, 2019
Actual Primary Completion Date January 1, 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: ovarian cancer
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03980028
Other Study ID Numbers 18 HLGENF 01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Institut Claudius Regaud
Study Sponsor Institut Claudius Regaud
Collaborators
  • Institut Bergonié
  • Institut Paoli-Calmettes
  • Institut du Cancer de Montpellier - Val d'Aurelle
  • Hospital Universitario La Paz
  • Hospital Vall d'Hebron
Investigators Not Provided
PRS Account Institut Claudius Regaud
Verification Date June 2019

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