Study Stopped
qualitative analysis of the study database
Pelvic and Aortic-cava Lymphadenectomy Randomized for Ovarian Cancer
CARACO
1 other identifier
interventional
450
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 ovarian-cancer
Started Dec 2008
Longer than P75 for phase_3 ovarian-cancer
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 9, 2008
CompletedFirst Submitted
Initial submission to the registry
October 8, 2010
CompletedFirst Posted
Study publicly available on registry
October 11, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedMay 16, 2019
May 1, 2019
17.4 years
October 8, 2010
May 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
survival with out recurrence
5 years
Study Arms (2)
lymphadenectomy
EXPERIMENTALafter surgery of the ovarian cancer, patient will have Pelvis and aortic-cava lymphadenectomy
no lymphadectomy
NO INTERVENTIONafter surgery, the patient will not have pelvic and aortic-cave lymphadenectomy
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Clinique Sainte Thérèse
Amiens, 80000, France
Centre Paul Papin
Angers, 49000, France
Hospital
Angers, 49000, France
Hospital
Brest, 29609, France
Centre Jean Perrin
Clermont-Ferrand, 63011, France
Centre G F Leclerc
Dijon, 21079, France
Hospital
Lyon, 69437, France
Institut Paoli Calmette
Marseille, 13009, France
Centre Val d'Aurelle
Montpellier, 34298, France
Hôpital Européen Georges Pompidou
Paris, 75000, France
Hôpital Lariboisière
Paris, 75010, France
Hôpital des Diaconesses
Paris, 75020, France
Clinique Mutualiste
Rennes, 35000, France
Hopital
Rennes, 35000, France
Centre René Huguenin
Saint-Cloud, 92210, France
Institut Cancerologie de l'Ouest
Saint-Herblain, 44805, France
Centre Paul Strauss
Strasbourg, 67065, France
Institut Claudius Regaud
Toulouse, 31052, France
Hôpital Bretonneau
Tours, 37044, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2010
First Posted
October 11, 2010
Study Start
December 9, 2008
Primary Completion
May 1, 2026
Study Completion
May 1, 2026
Last Updated
May 16, 2019
Record last verified: 2019-05