Ovarian Cancer Clinical Trial
— CARACOOfficial title:
Pelvic and Aortic-cava Lymphadenectomy Randomized Phase III for Advanced Ovarian Cancer
| Verified date | May 2019 |
| Source | Institut Cancerologie de l'Ouest |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Suspended |
| Enrollment | 450 |
| Est. completion date | May 2026 |
| Est. primary completion date | May 2026 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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) |
| Country | Name | City | State |
|---|---|---|---|
| France | Clinique Sainte Thérèse | Amiens | |
| France | Centre Paul Papin | Angers | |
| France | Hospital | Angers | |
| France | Hospital | Brest | |
| France | Centre Jean Perrin | Clermont-Ferrand | |
| France | Centre G F Leclerc | Dijon | |
| France | Hospital | Lyon | |
| France | Institut Paoli Calmette | Marseille | |
| France | Centre Val d'Aurelle | Montpellier | |
| France | Hôpital des Diaconesses | Paris | |
| France | Hôpital Européen Georges Pompidou | Paris | |
| France | Hôpital Lariboisière | Paris | |
| France | Clinique Mutualiste | Rennes | |
| France | Hopital | Rennes | |
| France | Centre René Huguenin | Saint Cloud | |
| France | Institut Cancerologie de l'Ouest | Saint Herblain | |
| France | Centre Paul Strauss | Strasbourg | |
| France | Institut Claudius Regaud | Toulouse | |
| France | Hôpital Bretonneau | Tours |
| Lead Sponsor | Collaborator |
|---|---|
| Institut Cancerologie de l'Ouest |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | survival with out recurrence | 5 years |
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