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

University of Roma La Sapienza

Status: Completed

Conditions: Endometrial Cancer

Treatments: Procedure: Systematic pelvic lymphadenectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00482300

PTC-CBM-15

Details and patient eligibility

About

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

Sex: Female

Ages: Under 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)