Systematic Pelvic Lymphadenectomy Versus no Lymphadenectomy in Clinical Stage I-II Endometrial Cancer

Not Applicable

Completed

• Conditions: Endometrial Cancer

• Registration Number: NCT00482300
• Lead Sponsor: University of Roma La Sapienza

Brief Summary

The purpose of this trial is to determine whether the addition of systematic pelvic lymphadenectomy to hysterectomy with bilateral adnexectomy improves disease-free survival (DFS) and overall survival (OS) in patients with preoperatively supposed Stage I-II endometrial cancer

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-03
• Study First Submitted: 2007-06-04
• Study First Submitted QC: 2007-06-04
• Last Update Submitted: 2007-06-04
• Study First Posted: 2007-06-05
• Last Update Posted: 2007-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Histologically proven endometrioid or adenosquamous endometrial carcinoma.
• Patients having myometrial invasion
• Age =/< 75 years
• Informed consent.

Exclusion Criteria

• Serous papillary and clear cell tumors.
• Karnofsky index < 80 or severe diseases contraindicating surgery
• Concomitant neoplasia (basalioma cutis excluded)
• Distant metastasis or abdominal metastasis detected intraoperatively.
• Absence of myometrial invasion at frozen section.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL