Role of Surgery in Advanced Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

Role of Surgery in Advanced Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03980028
• Other study ID #: 18 HLGENF 01
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: June 2019
• Source: Institut Claudius Regaud
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 550
• Est. completion date: June 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Locations

Country	Name	City	State
France	Institut Claudius Regaud - IUCT-Oncopole	Toulouse	Occitanie

Sponsors (6)

Lead Sponsor	Collaborator
Institut Claudius Regaud	Hospital Universitario La Paz, Hospital Vall d'Hebron, Institut Bergonié, Institut du Cancer de Montpellier - Val d'Aurelle, Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

References & Publications (8)

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. — View Citation

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. — View Citation

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 — View Citation

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 du — View Citation

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 — View Citation

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( — View Citation

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. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient survival	patient survival after surgery (patient record)	4 years
Primary	Evaluation of the tumor burden	Measurement of tumor size before surgery (patient record)	1 day
Secondary	Evaluation of the extension of carcinomatosis	Number of tumor nodules before surgery (patient record)	1 day
Secondary	Evaluation of the invasion of celiac lymph nodes	Number of celiac lymph nodes before surgery (patient record)	1 day
Secondary	Combination of surgical procedures	Number and type of combination of surgical procedures (patient record)	1 day