Pelvic and Aortic-cava Lymphadenectomy Randomized for Ovarian Cancer
Phase 3
Suspended
- Conditions
- Ovarian Cancer
- 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
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
- Primary Outcome Measures
Name Time Method survival with out recurrence 5 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (17)
Clinique Sainte Thérèse
🇫🇷Amiens, France
Centre Paul Papin
🇫🇷Angers, France
Hospital
🇫🇷Lyon, France
Centre Jean Perrin
🇫🇷Clermont-Ferrand, France
Centre G F Leclerc
🇫🇷Dijon, France
Institut Paoli Calmette
🇫🇷Marseille, France
Centre Val d'Aurelle
🇫🇷Montpellier, France
Hôpital Européen Georges Pompidou
🇫🇷Paris, France
Hôpital Lariboisière
🇫🇷Paris, France
Hôpital des Diaconesses
🇫🇷Paris, France
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