Pelvic and Aortic-cava Lymphadenectomy Randomized for Ovarian Cancer

NCT ID: NCT01218490

Last Updated: 2019-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE3

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-09

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ovarian Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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lymphadenectomy

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

Group Type EXPERIMENTAL

ovarian cancer surgery

Intervention Type PROCEDURE

no lymphadectomy

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ovarian cancer surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Institut Cancerologie de l'Ouest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinique Sainte Thérèse

Amiens, , France

Site Status

Centre Paul Papin

Angers, , France

Site Status

Hospital

Angers, , France

Site Status

Hospital

Brest, , France

Site Status

Centre Jean Perrin

Clermont-Ferrand, , France

Site Status

Centre G F Leclerc

Dijon, , France

Site Status

Hospital

Lyon, , France

Site Status

Institut Paoli Calmette

Marseille, , France

Site Status

Centre Val d'Aurelle

Montpellier, , France

Site Status

Hôpital Européen Georges Pompidou

Paris, , France

Site Status

Hôpital Lariboisière

Paris, , France

Site Status

Hôpital des Diaconesses

Paris, , France

Site Status

Clinique Mutualiste

Rennes, , France

Site Status

Hopital

Rennes, , France

Site Status

Centre René Huguenin

Saint-Cloud, , France

Site Status

Institut Cancerologie de l'Ouest

Saint-Herblain, , France

Site Status

Centre Paul Strauss

Strasbourg, , France

Site Status

Institut Claudius Regaud

Toulouse, , France

Site Status

Hôpital Bretonneau

Tours, , France

Site Status

Countries

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France

Other Identifiers

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SC 07/12-H

Identifier Type: -

Identifier Source: org_study_id

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