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

Endometrial Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00482300
• Other study ID #: PTC-CBM-15
• Status: Completed
• Phase: N/A
• First received: June 4, 2007
• Last updated: June 4, 2007

Study information

• Verified date: March 2007
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 75 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometrial Cancer

Intervention

Procedure:
• Systematic pelvic lymphadenectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza