Status:
SUSPENDED
Pelvic and Aortic-cava Lymphadenectomy Randomized for Ovarian Cancer
Lead Sponsor:
Institut Cancerologie de l'Ouest
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 9 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT01218490
Start Date
December 9 2008
End Date
May 1 2026
Last Update
May 16 2019
Active Locations (19)
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1
Clinique Sainte Thérèse
Amiens, France, 80000
2
Centre Paul Papin
Angers, France, 49000
3
Hospital
Angers, France, 49000
4
Hospital
Brest, France, 29609