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Pelvic and Aortic-cava Lymphadenectomy Randomized Phase III for Advanced Ovarian Cancer


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer

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Trial Information

Pelvic and Aortic-cava Lymphadenectomy Randomized Phase III for Advanced Ovarian Cancer


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

survival with out recurrence

Outcome Time Frame:

5 years

Safety Issue:

No

Authority:

france : Afssaps

Study ID:

SC 07/12-H

NCT ID:

NCT01218490

Start Date:

December 2008

Completion Date:

December 2016

Related Keywords:

  • Ovarian Cancer
  • surgery
  • ovarian cancer
  • lymphadectomy
  • Ovarian Neoplasms

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