CClinicalTrials.gg
SuspendedNCT01218490CARACOUpdated May 16, 2019

Pelvic and Aortic-cava Lymphadenectomy Randomized for Ovarian Cancer

A Phase 3 interventional study of ovarian cancer surgery in Ovarian Cancer, sponsored by Institut Cancerologie de l'Ouest. Suspended at 19 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-16.

Sponsored by Institut Cancerologie de l'Ouest · Phase 3, Interventional, and Other

Why this study was suspended
qualitative analysis of the study database

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Dec 2008, registered Oct 2010).
Phase
Phase 3
Study type
Interventional
Enrollment
450
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Ovarian Cancer

Keywords

  • surgery
  • ovarian cancer
  • lymphadectomy
03

In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's planned enrollment of 450 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Institut Cancerologie de l'Ouest is the lead sponsor of 105 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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)
05

Study design

Phase
Phase 3
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
450 participants (estimated)

Study arms

  • 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

Interventions

  • Procedureovarian cancer surgery
06

What researchers measure

Primary outcomes

  1. survival with out recurrence

    Time frame: 5 years

07

Study locations

19 sites
  • Clinique Sainte Thérèse
    Amiens, 80000, France
  • Centre Paul Papin
    Angers, 49000, France
  • Hospital
    Angers, 49000, France
  • Hospital
    Brest, 29609, France
  • Centre Jean Perrin
    Clermont-Ferrand, 63011, France
  • Centre G F Leclerc
    Dijon, 21079, France
  • Hospital
    Lyon, 69437, France
  • Institut Paoli Calmette
    Marseille, 13009, France
  • Centre Val d'Aurelle
    Montpellier, 34298, France
  • Hôpital Européen Georges Pompidou
    Paris, 75000, France
  • Hôpital Lariboisière
    Paris, 75010, France
  • Hôpital des Diaconesses
    Paris, 75020, France
  • Clinique Mutualiste
    Rennes, 35000, France
  • Hopital
    Rennes, 35000, France
  • Centre René Huguenin
    Saint Cloud, 92210, France
  • Institut Cancerologie de l'Ouest
    Saint Herblain, 44805, France
  • Centre Paul Strauss
    Strasbourg, 67065, France
  • Institut Claudius Regaud
    Toulouse, 31052, France
  • Hôpital Bretonneau
    Tours, 37044, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01218490
Lead sponsor
Institut Cancerologie de l'Ouest
Responsible party
Sponsor
First posted
Oct 11, 2010
Start date
Dec 9, 2008
Primary completion
May 2026 (estimated)
Completion
May 2026 (estimated)
Last update
May 16, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in May 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion