Role of Surgery in Advanced Ovarian Cancer

Completed

• Conditions: Ovarian Cancer

• Registration Number: NCT03980028
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-01-01
• Primary Completion: 2019-01-01
• Status Verified: 2019-06
• Study Completion: 2019-06-01
• Study First Submitted: 2019-06-04
• Study First Submitted QC: 2019-06-06
• Last Update Submitted: 2019-06-06
• Study First Posted: 2019-06-10
• Last Update Posted: 2019-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 550

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient survival	4 years	patient survival after surgery (patient record)
Evaluation of the tumor burden	1 day	Measurement of tumor size before surgery (patient record)

Secondary Outcome Measures

Name	Time	Method
Evaluation of the invasion of celiac lymph nodes	1 day	Number of celiac lymph nodes before surgery (patient record)
Evaluation of the extension of carcinomatosis	1 day	Number of tumor nodules before surgery (patient record)
Combination of surgical procedures	1 day	Number and type of combination of surgical procedures (patient record)

Trial Locations

Locations (1)

Institut Claudius Regaud - IUCT-Oncopole; 🇫🇷 Toulouse, Occitanie, France