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Pelvic and Aortic-cava Lymphadenectomy Randomized for Ovarian Cancer (CARACO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01218490
Recruitment Status : Suspended (qualitative analysis of the study database)
First Posted : October 11, 2010
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Procedure: ovarian cancer surgery Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pelvic and Aortic-cava Lymphadenectomy Randomized Phase III for Advanced Ovarian Cancer
Actual Study Start Date : December 9, 2008
Estimated Primary Completion Date : May 2026
Estimated Study Completion Date : May 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Experimental: lymphadenectomy
after surgery of the ovarian cancer, patient will have Pelvis and aortic-cava lymphadenectomy
Procedure: ovarian cancer surgery
No Intervention: no lymphadectomy
after surgery, the patient will not have pelvic and aortic-cave lymphadenectomy



Primary Outcome Measures :
  1. survival with out recurrence [ Time Frame: 5 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01218490


Locations
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France
Clinique Sainte Thérèse
Amiens, France, 80000
Centre Paul Papin
Angers, France, 49000
Hospital
Angers, France, 49000
Hospital
Brest, France, 29609
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Centre G F Leclerc
Dijon, France, 21079
Hospital
Lyon, France, 69437
Institut Paoli Calmette
Marseille, France, 13009
Centre Val d'Aurelle
Montpellier, France, 34298
Hôpital Européen Georges Pompidou
Paris, France, 75000
Hôpital Lariboisière
Paris, France, 75010
Hôpital des Diaconesses
Paris, France, 75020
Clinique Mutualiste
Rennes, France, 35000
Hopital
Rennes, France, 35000
Centre René Huguenin
Saint Cloud, France, 92210
Institut Cancerologie de l'Ouest
Saint Herblain, France, 44805
Centre Paul Strauss
Strasbourg, France, 67065
Institut Claudius Regaud
Toulouse, France, 31052
Hôpital Bretonneau
Tours, France, 37044
Sponsors and Collaborators
Institut Cancerologie de l'Ouest

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Responsible Party: Institut Cancerologie de l'Ouest
ClinicalTrials.gov Identifier: NCT01218490     History of Changes
Other Study ID Numbers: SC 07/12-H
First Posted: October 11, 2010    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Keywords provided by Institut Cancerologie de l'Ouest:
surgery
ovarian cancer
lymphadectomy
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Carcinoma