Pelvic and Aortic-cava Lymphadenectomy Randomized for Ovarian Cancer

Phase 3

Suspended

• Conditions: Ovarian Cancer
• Interventions: Procedure: ovarian cancer surgery

• Registration Number: NCT01218490
• Lead Sponsor: Institut Cancerologie de l'Ouest

Brief Summary

It is a multicenter randomized trial of superior cleaning compared the absence of dissection in stage III patients with optimal surgical resection without retroperitoneal lymph node palpable.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-09
• Study First Submitted: 2010-10-08
• Study First Submitted QC: 2010-10-08
• Study First Posted: 2010-10-11
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-14
• Last Update Posted: 2019-05-16
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Female
• Target Recruitment: 450

Inclusion Criteria

• Age> 18 years
• Karnofsky> 80, or ASA I-II
• Primary ovarian adenocarcinoma, or primitive peritoneal
• No retroperitoneal lymph node> 2cm (CT; MRI)
• Complete surgical staging
• Stage III-IV FIGO classification
• Indication of systemic chemotherapy before surgery or post surgery

Exclusion Criteria

• Non Invasive Cancer
• non-epithelial or borderline cancer
• Pregnancy
• Previous pelvic lymphadenectomy or aortic-cava for a disease other than ovarian cancer
• Contraindication to Platinum and Paclitaxel
• Borderline Ovarian Tumor
• tumor recurrence
• Incomplete surgery, resectable lesion, Surgery sub optimal (R> 1cm)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lymphadenectomy	ovarian cancer surgery	after surgery of the ovarian cancer, patient will have Pelvis and aortic-cava lymphadenectomy

Primary Outcome Measures

Name	Time	Method
survival with out recurrence	5 years

Trial Locations

Locations (17)

Clinique Sainte Thérèse; 🇫🇷 Amiens, France

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France

Centre G F Leclerc; 🇫🇷 Dijon, France

Hospital; 🇫🇷 Lyon, France

Institut Paoli Calmette; 🇫🇷 Marseille, France

Centre Val d'Aurelle; 🇫🇷 Montpellier, France

Hôpital Européen Georges Pompidou; 🇫🇷 Paris, France

Hopital; 🇫🇷 Rennes, France

Hôpital Lariboisière; 🇫🇷 Paris, France

Hôpital des Diaconesses; 🇫🇷 Paris, France

Clinique Mutualiste; 🇫🇷 Rennes, France

Institut Cancerologie de l'Ouest; 🇫🇷 Saint Herblain, France

Centre René Huguenin; 🇫🇷 Saint Cloud, France

Institut Claudius Regaud; 🇫🇷 Toulouse, France

Centre Paul Strauss; 🇫🇷 Strasbourg, France

Hôpital Bretonneau; 🇫🇷 Tours, France

Centre Paul Papin; 🇫🇷 Angers, France