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

May 14, 2019 updated by: Institut Cancerologie de l'Ouest

Pelvic and Aortic-cava Lymphadenectomy Randomized Phase III for Advanced Ovarian Cancer

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

450

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
survival with out recurrence
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Cancerologie de l'Ouest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2008

Primary Completion (Anticipated)

May 1, 2026

Study Completion (Anticipated)

May 1, 2026

Study Registration Dates

First Submitted

October 8, 2010

First Submitted That Met QC Criteria

October 8, 2010

First Posted (Estimate)

October 11, 2010

Study Record Updates

Last Update Posted (Actual)

May 16, 2019

Last Update Submitted That Met QC Criteria

May 14, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SC 07/12-H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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