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

This study has been completed.
Information provided by:
University of Roma La Sapienza Identifier:
First received: June 4, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
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

Condition Intervention
Endometrial Cancer Procedure: Systematic pelvic lymphadenectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by University of Roma La Sapienza:


Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00482300

Sponsors and Collaborators
University of Roma La Sapienza
Study Chair: Pierluigi Benedetti Panici, Full Professor Department of Obstetrics and Gynecology University La Sapienza of Rome
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00482300     History of Changes
Other Study ID Numbers: PTC-CBM-15
Study First Received: June 4, 2007
Last Updated: June 4, 2007

Keywords provided by University of Roma La Sapienza:
Histologically proved endometrial carcinoma preoperatively supposed stage I-II

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female processed this record on August 18, 2017