Trial record 17 of 679 for:    ovarian cancer | Open Studies

Pelvic and Aortic-cava Lymphadenectomy Randomized for Ovarian Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2010 by Centre René Gauducheau
Sponsor:
Information provided by:
Centre René Gauducheau
ClinicalTrials.gov Identifier:
NCT01218490
First received: October 8, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose

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 Intervention Phase
Ovarian Cancer
Procedure: ovarian cancer surgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Pelvic and Aortic-cava Lymphadenectomy Randomized Phase III for Advanced Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by Centre René Gauducheau:

Primary Outcome Measures:
  • survival with out recurrence [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 450
Study Start Date: December 2008
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Procedure: ovarian cancer surgery

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01218490

Locations
France
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         
Hospital Recruiting
Lyon, France, 69437
Contact: Patrice Mathevet, Md    +33472117730      
Principal Investigator: Patrice Mathevet, MD         
Centre Léon Berard Withdrawn
Lyon, France, 69373
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 Lariboisière Recruiting
Paris, France, 75010
Contact: Emmanuel Barranger, MD    +33149956565      
Principal Investigator: Emmanuel Barranger, 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 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         
Centre René Gauducheau Recruiting
Saint Herblain, France, 44805
Contact: Evelyne Scotet-Cérato    +33253482840    evelyne.cerato@chu-nantes.fr   
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
Centre René Gauducheau
  More Information

No publications provided

Responsible Party: Dr Classe Jean Marc, Centre René Gauducheau
ClinicalTrials.gov Identifier: NCT01218490     History of Changes
Other Study ID Numbers: SC 07/12-H
Study First Received: October 8, 2010
Last Updated: October 8, 2010
Health Authority: france : Afssaps

Keywords provided by Centre René Gauducheau:
surgery
ovarian cancer
lymphadectomy

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

ClinicalTrials.gov processed this record on July 31, 2014