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

Primary Purpose

Ovarian Cancer

Status
Suspended
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
ovarian cancer surgery
Sponsored by
Institut Cancerologie de l'Ouest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Ovarian Cancer focused on measuring surgery, ovarian cancer, lymphadectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Clinique Sainte Thérèse
  • Centre Paul Papin
  • Hospital
  • Hospital
  • Centre Jean Perrin
  • Centre G F Leclerc
  • Hospital
  • Institut Paoli Calmette
  • Centre Val d'Aurelle
  • Hôpital Européen Georges Pompidou
  • Hôpital Lariboisière
  • Hôpital des Diaconesses
  • Clinique Mutualiste
  • Hopital
  • Centre René Huguenin
  • Institut Cancerologie de l'Ouest
  • Centre Paul Strauss
  • Institut Claudius Regaud
  • Hôpital Bretonneau

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

lymphadenectomy

no lymphadectomy

Arm Description

after surgery of the ovarian cancer, patient will have Pelvis and aortic-cava lymphadenectomy

after surgery, the patient will not have pelvic and aortic-cave lymphadenectomy

Outcomes

Primary Outcome Measures

survival with out recurrence

Secondary Outcome Measures

Full Information

First Posted
October 8, 2010
Last Updated
May 14, 2019
Sponsor
Institut Cancerologie de l'Ouest
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1. Study Identification

Unique Protocol Identification Number
NCT01218490
Brief Title
Pelvic and Aortic-cava Lymphadenectomy Randomized for Ovarian Cancer
Acronym
CARACO
Official Title
Pelvic and Aortic-cava Lymphadenectomy Randomized Phase III for Advanced Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Suspended
Why Stopped
qualitative analysis of the study database
Study Start Date
December 9, 2008 (Actual)
Primary Completion Date
May 2026 (Anticipated)
Study Completion Date
May 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Cancerologie de l'Ouest

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
surgery, ovarian cancer, lymphadectomy

7. Study Design

Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
lymphadenectomy
Arm Type
Experimental
Arm Description
after surgery of the ovarian cancer, patient will have Pelvis and aortic-cava lymphadenectomy
Arm Title
no lymphadectomy
Arm Type
No Intervention
Arm Description
after surgery, the patient will not have pelvic and aortic-cave lymphadenectomy
Intervention Type
Procedure
Intervention Name(s)
ovarian cancer surgery
Primary Outcome Measure Information:
Title
survival with out recurrence
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
Clinique Sainte Thérèse
City
Amiens
ZIP/Postal Code
80000
Country
France
Facility Name
Centre Paul Papin
City
Angers
ZIP/Postal Code
49000
Country
France
Facility Name
Hospital
City
Angers
ZIP/Postal Code
49000
Country
France
Facility Name
Hospital
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
Centre G F Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Hospital
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Institut Paoli Calmette
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Centre Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Hôpital Européen Georges Pompidou
City
Paris
ZIP/Postal Code
75000
Country
France
Facility Name
Hôpital Lariboisière
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hôpital des Diaconesses
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Clinique Mutualiste
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
Hopital
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
Centre René Huguenin
City
Saint Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
Institut Cancerologie de l'Ouest
City
Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Centre Paul Strauss
City
Strasbourg
ZIP/Postal Code
67065
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31052
Country
France
Facility Name
Hôpital Bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

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Pelvic and Aortic-cava Lymphadenectomy Randomized for Ovarian Cancer

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