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

Institut Cancerologie de l'Ouest

Status and phase: Suspended; Phase 3

Conditions: Ovarian Cancer

Treatments: Procedure: ovarian cancer surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01218490

SC 07/12-H

Details and patient eligibility

About

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.

Enrollment: 450 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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450 participants in 2 patient groups

lymphadenectomy

Experimental group

Description:

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

Treatment:

Procedure: ovarian cancer surgery

no lymphadectomy

No Intervention group

Description:

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