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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01218490
Recruitment Status : Recruiting
First Posted : October 11, 2010
Last Update Posted : August 31, 2016
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Pelvic and Aortic-cava Lymphadenectomy Randomized Phase III for Advanced Ovarian Cancer
Study Start Date : December 2008
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2022

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 ]

Information from the National Library of Medicine

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

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 identifier (NCT number): NCT01218490

Clinique Sainte Thérèse Not yet recruiting
Amiens, France, 80000
Contact: Joël Isapof, MD         
Principal Investigator: Joel Isapof, MD         
Centre Paul Papin Recruiting
Angers, France, 49000
Contact: Gérard Lorimier, MD    +330241352700      
Principal Investigator: Gérard Lorimier, MD         
Hospital Recruiting
Angers, France, 49000
Contact: Philippe Descamps, MD    +330241354255      
Principal Investigator: Philippe Descamps, MD         
Hospital Recruiting
Brest, France, 29609
Contact: Pierre-François Dupré, MD    +330298223333      
Principal Investigator: Pierre-François Dupré, MD         
Centre Jean Perrin Recruiting
Clermond Ferrand, France, 63011
Contact: Guillaume Lebouedec, Md    +33 473278195      
Principal Investigator: Guillaume Lebouedec, MD         
Centre G F Leclerc Recruiting
Dijon, France, 21079
Contact: Jean Fraisse, MD    +33380737508      
Principal Investigator: Jean Fraisse, MD         
Centre Léon Berard Withdrawn
Lyon, France, 69373
Hospital Recruiting
Lyon, France, 69437
Contact: Patrice Mathevet, Md    +33472117730      
Principal Investigator: Patrice Mathevet, MD         
Institut Paoli Calmette Recruiting
Marseille, France, 13009
Contact: Gilles Houvenaeghel, MD    +33467613015      
Principal Investigator: Gilles Houvenaeghel, MD         
Centre Val d'Aurelle Not yet recruiting
Montpellier, France, 34298
Contact: Philippe Rouanet, MD    +33467613071      
Principal Investigator: Philippe Rouanet, MD         
Hôpital Européen Georges Pompidou Recruiting
Paris, France, 75000
Contact: Fabrice Lecurur, MD    +330156093584      
Principal Investigator: Fabrice Lecurur, MD         
Principal Investigator: fabrice Lecuru, MD         
Hôpital Lariboisière Recruiting
Paris, France, 75010
Contact: Emmanuel Barranger, MD    +33149956565      
Principal Investigator: Emmanuel Barranger, MD         
Hôpital des Diaconesses Recruiting
Paris, France, 75020
Contact: Richard Villet, MD    +33144641600      
Principal Investigator: Richard Villet, MD         
Clinique Mutualiste Recruiting
Rennes, France, 35000
Contact: Jean Vialard, MD    +33299857510      
Principal Investigator: Jean Vialiard, MD         
Hopital Recruiting
Rennes, France, 35000
Contact: Jean Leveque, MD    +33299267171      
Principal Investigator: Jean Leveque, MD         
Centre René Huguenin Recruiting
Saint Cloud, France, 92210
Contact: Serges Lasry, MD    +33147111515      
Principal Investigator: Serge Larsry, MD         
Institut Cancerologie de l'Ouest Recruiting
Saint Herblain, France, 44805
Contact: Valérie PACTEAU    +33240679900 ext 9168   
Principal Investigator: Jean Marc Classe, MD         
Centre Paul Strauss Recruiting
Strasbourg, France, 67065
Contact: Jean François Rodier, MD    +33388252427      
Principal Investigator: Jean François Rodier, MD         
Institut Claudius Regaud Recruiting
Toulouse, France, 31052
Contact: Denis Querleu, MD    +33561424148      
Principal Investigator: Denis Querleu, MD         
Hôpital Bretonneau Recruiting
Tours, France, 37044
Contact: Gilles Body, MD    +33247473815      
Principal Investigator: Gilles Body, MD         
Sponsors and Collaborators
Institut Cancerologie de l'Ouest

Responsible Party: Institut Cancerologie de l'Ouest Identifier: NCT01218490     History of Changes
Other Study ID Numbers: SC 07/12-H
First Posted: October 11, 2010    Key Record Dates
Last Update Posted: August 31, 2016
Last Verified: August 2016

Keywords provided by Institut Cancerologie de l'Ouest:
ovarian cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders